ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX
Received Jul 11, 2025
Report 3000302531-2025-00321 · MDR key 22477710
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
3771Lot number
BH31551710
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Male
- Laceration(s)
- Laceration(s)
Narrative
Description of Event or Problem
CUTS IN MY MOUTH [MOUTH INJURY] BRUSH HEAD FELL OFF [DEVICE BREAKAGE] CASE NARRATIVE: CONSUMER CALLED STATING THE TOOTHBRUSH HEAD FELL OFF AND CAUSED CUTS IN MOUTH. NO SERIOUS INJURY REPORTED. FOLLOW-UP (PRODUCT INVESTIGATION RESULTS) (22-10-2025): PRODUCT INVESTIGATION RESULT FOR THE SUSPECTS ORAL-B TOOTHBRUSH HANDLE WAS RECEIVED. THE RECEIVED HANDLE IS NOT FUNCTIONING AND CHARGING ON RECEIVED STATE. BASED ON INVESTIGATION RESULTS, "NO MANUFACTURING CAUSE" AND "NO DESIGN ISSUE" WAS IDENTIFIED. NO SERIOUS INJURY WAS REPORTED. FOLLOW-UP (PRODUCT INVESTIGATION RESULTS) (19-11-2025): PRODUCT INVESTIGATION RESULT FOR THE SUSPECTS ORAL-B TOOTHBRUSH HANDLE WAS RECEIVED. THE RECEIVED HANDLE IS NOT FUNCTIONING AND CHARGING ON RECEIVED STATE. CAUSE OF FAILURE WAS FOUND TO BE MANIPULATION; SOLDERING AND REWORK BY UNKNOWN SOURCE LEADS TO DISCONNECTION OF BATTERY WITH PCB AND NO FAILURE FOUND RELATED TO THE "LOOSE IN MOUTH". BASED ON INVESTIGATION RESULTS, "NO MANUFACTURING CAUSE" AND "NO DESIGN ISSUE" WAS IDENTIFIED. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
(B)(6) 2025 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND EVALUATED. NO FAILURE COULD BE IDENTIFIED, THE PRODUCT IS ACCORDING TO SPECIFICATIONS.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN. H3 OTHER TEXT : PENDING INVESTIGATION.
Description of Event or Problem
CUTS IN MY MOUTH [MOUTH INJURY] . BRUSH HEAD FELL OFF [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER CALLED STATING THE TOOTHBRUSH HEAD FELL OFF AND CAUSED CUTS IN MOUTH. NO SERIOUS INJURY REPORTED. FOLLOW-UP (PRODUCT INVESTIGATION RESULTS) (22-10-2025): PRODUCT INVESTIGATION RESULT FOR THE SUSPECTS ORAL-B TOOTHBRUSH HANDLE WAS RECEIVED. THE RECEIVED HANDLE IS NOT FUNCTIONING AND CHARGING ON RECEIVED STATE. BASED ON INVESTIGATION RESULTS, "NO MANUFACTURING CAUSE" AND "NO DESIGN ISSUE" WAS IDENTIFIED. NO SERIOUS INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem
CUTS IN MY MOUTH [MOUTH INJURY] BRUSH HEAD FELL OFF [DEVICE BREAKAGE] . CASE NARRATIVE: CONSUMER CALLED STATING THE TOOTHBRUSH HEAD FELL OFF AND CAUSED CUTS IN MOUTH. NO SERIOUS INJURY REPORTED.