ORALBPWRORALCARERFLS3DWHITEEB18
Received May 17, 2024
Report 3000302531-2024-00226 · MDR key 19340340
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
EB18Lot number
C9208
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
81 YR · Female
- 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
THE HEAD SHEARED OFF - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: A RELATIVE VIA E-MAIL REPORTED THAT THEIR 81-YEAR-OLD MOTHER WAS CLEANING HER TEETH WHEN THE ORAL-B TOOTHBRUSH HEAD SHEARED OFF. NO INJURY WAS REPORTED.
Description of Event or Problem
THE HEAD SHEARED OFF - ORAL-B [DEVICE BREAKAGE] CASE NARRATIVE: A RELATIVE VIA E-MAIL REPORTED THAT THEIR 81-YEAR-OLD MOTHER WAS CLEANING HER TEETH WHEN THE ORAL-B TOOTHBRUSH HEAD SHEARED OFF. NO INJURY WAS REPORTED. 22-MAY-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 10-MAY-2024: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS 3D WHITE EB18. NO INJURY WAS REPORTED. 28-JUL-2024 CASE UPDATE FROM INFORMATION INITIALLY RECEIVED ON 11-JUN-2024: THE SUSPECT PRODUCT LOT NUMBER C9208. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
2024 PRODUCT INVESTIGATION RESULTS: COMPLAINED PRODUCT RECEIVED - USER HANDLING WAS IDENTIFIED AS ROOT CAUSE FOR THE COMPLAINT.