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Important Safety Information - BHM/Medi-Man Combi Sling - Possible Stitching Failure - Notice to Hospitals

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Contact:Marketed Health Products Directorate (MHPD)

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from BHM Medical Inc.
Contact the company for a copy of any references, attachments or enclosures.

NOTICE TO HOSPITALS
Health Canada Endorsed Important Safety Information on BHM/Medi-Man Combi Sling

April 3, 2009

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery; Emergency Medecine, Pediatrics, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required, and other involved professional staff and post this Notice in your institution.

Subject: BHM/Medi-Man Combi Sling – Possible Stitching Failure

Product Family: Sling

Document Number: FSN10/2009/ca

Distribution: All end users

Scope
This notice pertains to all Combi model slings manufactured by BHM Medical and Medi-Man and sold under the following product number:

Combi slings can be identified by looking for the following characteristics:

Characteristics

1. Yellow, green and white shoulder straps
2. Handle in the back
3. Green strap in the back
4. White main color
5. Orange, black and white leg straps

These slings were labeled under the BHM or Medi-Man brand.

Background
This notice relates to premature failure of the stitching at the junction of the shoulder strap and the sling body which can be noticed during routine inspection. The failure of the stitching is not sudden but gradual; therefore it is highly unlikely that a sling that has been inspected and considered suitable for use prior to a transfer would fail during that transfer.

Figure 1: Premature failure of the stitching

Health Hazard Analysis
An undetected stitching failure can ultimately lead to the detachment of the shoulder strap resulting in a possible patient fall. This may lead to serious personal injuries or worse to both patient and/or caregiver.

Actions to Take

1. Make sure you carefully read fully and understand this field safety notice.
2. Make sure this notice is distributed to all those who need to be aware within your organization or to any organization where the potentially affected slings have been transferred.
3. Inspect and assess your slings suitability for use as per the Slings Maintenance Instruction (001.03685) originally provided with your sling. Look closely for thread breakage at the junction of the shoulder strap and the sling body as shown in the Figure 2. If your sling is showing this kind of breakage, remove your sling from use and discard it immediately. If the inspection reveals no deterioration of the stitching, the sling is safe to use and can be returned to use.
   
   Figure 2: Example of partial thread breakage
   
   
   
   
4. Follow the General Care Guidelines section of the Slings Maintenance Instructions, namely the directives "It is imperative that a patient transfer sling be inspected prior to each use."

Next Step
Actions have already been initiated for the redesign of the Combi sling. The improved Combi Sling is expected to be available in May 2009.

You will be contacted for the replacement of your eligible old slings. Slings which have been in use for up to two (2) years will be replaced at no charge.

If you have any further questions or special needs, please contact our service department at:

BHM Medical Inc.
2001 Tanguay, Magog, QC, Canada J1X 5Y5
Telephone: 819-868-0441 Toll free: 1-800-868-0441
Fax: 819-868-2249
E-mail: service@bhm-medical.com

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious specific adverse incident or other serious or unexpected adverse incidents in patients using BHM/Medi-Man Combi Sling should be reported to BHM Medical Inc. or Health Canada at the following address: