ORALBPWRORALCARERFLSSENSIULTRATHINEB60BRUSHSET4CT
Received Sep 18, 2024
Report 3000302531-2024-00424 · MDR key 20245042
Device
Generic name
Toothbrush, Powered - Jeq
Manufacturer
Braun Gmbh Werk MarktheidenfeldModel number
EB60Lot number
C636
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
HEAD BROKE OFF IN MOUTH - ORAL-B [DEVICE BREAKAGE]. CASE NARRATIVE: FEMALE CONSUMER VIA E-MAIL STATED THAT THE ORAL-B PRO SENSITIVE CLEAN ELECTRIC TOOTHBRUSH HEAD BROKE OFF IN HER MOUTH. NO INJURY WAS REPORTED. 05-SEP-2024 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS C636. NO INJURY WAS REPORTED.
Additional Manufacturer Narrative
PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Additional Manufacturer Narrative
ON 08-OCT-2024 PRODUCT INVESTIGATION RESULTS: PRODUCT RETURN WAS RECEIVED AND IDENTIFIED AS A NON-GENUINE ORAL-B PRODUCT, IT WAS NOT MANUFACTURED UNDER P&G CONTROL.
Description of Event or Problem
HEAD BROKE OFF IN MOUTH - ORAL-B [DEVICE BREAKAGE]. PRODUCT COUNTERFEIT - ORAL-B [PRODUCT COUNTERFEIT]. CASE NARRATIVE: FEMALE CONSUMER VIA E-MAIL STATED THAT THE ORAL-B PRO SENSITIVE CLEAN ELECTRIC TOOTHBRUSH HEAD BROKE OFF IN HER MOUTH. NO INJURY WAS REPORTED. ON 05-SEP-2024 CASE UPDATE: THE SUSPECT PRODUCT LOT WAS C636. NO INJURY WAS REPORTED. ON 08-OCT-2024 PRODUCT INVESTIGATION RESULTS: THE PRODUCT INVOLVED WAS CONFIRMED TO BE A COUNTERFEIT, SO THE PRODUCT PROBLEM WILL BE REMOVED FROM THE ORAL-B TOOTHBRUSH HEAD REFILL. NO INJURY WAS REPORTED.