Urgent Product Removal Oral-B CrossAction Power and PowerMAX Toothbrushes and refills - Updated 2004-11-30 - For the Public

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Contact: Drug Compliance Verification & Investigation Unit

October 27, 2004

Subject: URGENT PRODUCT REMOVAL ORAL-B CROSSACTION POWER AND POWERMAX TOOTHBRUSHES AND REFILLS

Dear Consumers:

We want to inform you about reports we have received concerning instances where the brush head of an Oral-B CrossAction Power or PowerMAX toothbrush has become loose in the mouth during brushing.

A. Special Instructions to Caregivers

There have been three reported incidents that occurred while consumers were using our Oral-B CrossAction Power and PowerMAX toothbrushes and refills to assist in brushing the teeth of persons with special needs, such as cerebral palsy or autism. During brushing, the head of the toothbrush became unlatched, and the loose brush head was caught in the throat or swallowed. This may have occurred when the release latch was bitten or hit by front teeth. None of the consumers suffered any permanent injury, but medical assistance was required.

We therefore recommend that consumers stop using the CrossAction Power or PowerMAX toothbrushes and brush refills to assist in brushing the teeth of people with special needs. No other Oral-B product is affected.

Please note ONLY the Cross Action Power, Cross Action Power Max and Cross Action Power Refills are eligible for this refund. Consumers are requested to call the toll free number 1-800-496-6557 between the hours of 9:00 a.m. to 5:00 p.m. (EST) on Monday through Friday. To be reimbursed for your Cross Action Power product, send the toothbrush and /or refills and your name and address to the following address:

Oral B Products, Attn: B1010
4 Robert Speck Parkway
Suite 1000
Mississauga, ON
L4Z 4C5

We will arrange to reimburse you for your toothbrush and/or refills and your shipping charges. Please allow 6 - 8 weeks to receive your refund.

Also, caregivers can find helpful information about brushing the teeth of people with special needs on the website of the American Dental Association:

http://www.ada.org/public/topics/special_needs.asp

and on the website of the Canadian Dental Association:

http://www.cda-adc.ca/english/your_oral_health/caring_teeth/
dental_care_seniors/caring.asp

B. Information for Other Consumers

In addition, among consumers without special needs, there have been a small number of reports of brush heads being loose in the mouth. None of these consumers swallowed the brush head, no medical assistance was needed, and there were no reports of any permanent injury. We recommend that all consumers use care not to bite down on the brush head during brushing.

C. General Information

Gillette is redesigning the brush heads for these toothbrushes to eliminate issues related to the unlatching of the brush head. The new brush head refills, when available, will fit into the current CrossAction Power and PowerMAX toothbrushes. The new Oral-B CrossAction Power and CrossAction PowerMAX toothbrushes and brush refills are scheduled to be available in stores in January 2005.

You can call 1-800-496-6557 as noted above if you have any questions regarding the use of these products or this notice.

Please note that we are taking these actions because consumer safety is the number one concern at Oral-B. This action is being conducted with the knowledge of Health Canada.

Thank you for your continued support of Oral-B products.

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals and consumers in adverse incident reporting programmes. Any occurrences of serious and/or unexpected adverse incidents should be reported to Health Canada at the following address: