ORALBRCHGTOOTHBRUSHHANDLE4729
Received Oct 30, 2024
Report 3000302531-2024-00524 · MDR key 20570524
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
4729Lot number
1BB10551103
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
BATTERY FOR TOOTHBRUSH HAS EXPANDED AND THAT THE TOOTHBRUSH HAS BURST/TEAR/RIP - ORAL-B [DEVICE BREAKAGE] BATTERY FOR TOOTHBRUSH HAS EXPANDED...LIQUID LEAKED OUT/STICKY - ORAL-B [DEVICE LEAKAGE] CASE NARRATIVE: A PARENT VIA E-MAIL STATED THAT THE BATTERY FOR THEIR SON¿S ORAL-B TOOTHBRUSH EXPANDED AND BURST. THE LIQUID LEAKED OUT. NO INJURY WAS REPORTED. (B)(6) 2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. THE SUSPECT PRODUCT LOT WAS 1BB10551103. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
28-NOV-2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.
Description of Event or Problem
BATTERY FOR TOOTHBRUSH HAS EXPANDED AND THAT THE TOOTHBRUSH HAS BURST/TEAR/RIP - ORAL-B [DEVICE BREAKAGE]. BATTERY FOR TOOTHBRUSH HAS EXPANDED...LIQUID LEAKED OUT/STICKY - ORAL-B [DEVICE LEAKAGE]. CASE NARRATIVE: A PARENT VIA E-MAIL STATED THAT THE BATTERY FOR THEIR SON¿S ORAL-B TOOTHBRUSH EXPANDED AND BURST. THE LIQUID LEAKED OUT. NO INJURY WAS REPORTED. 09-OCT-2024 FOLLOW UP VIA PICTURES: THE SUSPECT PRODUCT WAS ORAL-B RECHARGEABLE TOOTHBRUSH HANDLE 4729. THE SUSPECT PRODUCT LOT WAS 1BB10551103. NO INJURY WAS REPORTED.