inforMED
MalfunctionJEQ

ORALBRCHGTOOTHBRUSHHANDLE3771GENIUSX

Received Jul 11, 2025

Report 3000302531-2025-00321 · MDR key 22477710

Device

Generic name

Toothbrush, Powered - Jeq

Model number

3771

Lot 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.