ORALBPWRBATTTOOTHBRUSHHANDLE4732CROSSACTNPWR
Received May 22, 2019
Report 3000302531-2019-00093 · MDR key 8632926
Device
Generic name
Toothbrush, Powered
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
4732Lot number
NOT AVAILABLE
Product problems
- Break
- Detachment of Device or Device Component
Patient
53 YR
- Pain
- Injury
- Pain
- Injury
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2019 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND INVESTIGATED. PRODUCT INVESTIGATION RESULTS SHOWED THAT COMPLAINT WAS CAUSED BY A BREAKAGE OF THE REFILL DUE TO IMPROPER CONSUMER HANDLING.
Description of Event or Problem
A SORE INSIDE OF TOP LIP ON THE SIDE [CHEILITIS]. LIP CAUGHT ON TOOTHBRUSH HEAD [LIP INJURY]. SORENESS/INSIDE OF TOP LIP ON THE SIDE [LIP PAIN]. BOTTOM BRUSH HEAD CAME APART IN MOUTH / SQUARE BRUSH PART CAME OFF IN MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA PHONE AND STATED THAT THE BOTTOM BRUSH HEAD CAME APART IN HER MOUTH, THE SQUARE BRUSH PART CAME OFF. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS RECEIVED AND PRODUCT INVESTIGATION IS IN PROGRESS.
Description of Event or Problem
A SORE INSIDE OF TOP LIP ON THE SIDE [CHEILITIS]. LIP CAUGHT ON TOOTHBRUSH HEAD [LIP INJURY]. SORENESS/INSIDE OF TOP LIP ON THE SIDE [LIP PAIN]. BOTTOM BRUSH HEAD CAME APART IN MOUTH / SQUARE BRUSH PART CAME OFF IN MOUTH [DEVICE BREAKAGE]. CASE DESCRIPTION: CONSUMER CONTACTED VIA PHONE AND STATED THAT THE BOTTOM BRUSH HEAD CAME APART IN HER MOUTH, THE SQUARE BRUSH PART CAME OFF. NO SERIOUS INJURY WAS REPORTED.