ORALBPWRORALCARERFLSCROSSACTNEB50
Report
- Report Number
- 3000302531-2024-00561
- Event Type
- Malfunction
- Date Received
- November 18, 2024
- Report Date
- December 15, 2024
- Manufacturer
- BRAUN GMBH WERK MARKTHEIDENFELD
- Product Code
- JEQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
06-DEC-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.
PRODUCT RETURN WAS REQUESTED OR ITS IN TRANSPORT. EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
LIP BLEED [LIP HAEMORRHAGE], CATCHES, NIP, CUTS - LIPS [LIP INJURY], CATCHES, NIP, CUTS - MOUTH, INSIDE CHEEK [MOUTH INJURY], CATCHES, NIP - TONGUE [TONGUE INJURY], PAINFUL / SORE MOUTH, CHEEK [ORAL PAIN], PAINFUL / SORE - TONGUE [GLOSSODYNIA], PAINFUL / SORE - LIP [LIP PAIN], HEAD OF MY TOOTHBRUSH HAS BECOME LOOSE - ORAL-B [DEVICE CONNECTION ISSUE] AND PRODUCT COUNTERFEIT - ORAL-B [PRODUCT COUNTERFEIT] . CASE NARRATIVE: CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD BECAME LOOSE AND CAUGHT THEIR CHEEK, LIP, AND TONGUE GIVING THEM A NIP WHICH WAS PAINFUL AND MADE THEIR LIP BLEED. NO SERIOUS INJURY WAS REPORTED. 19-OCT-2024 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT LOT WAS 1047786000. NO SERIOUS INJURY WAS REPORTED. 22-OCT-2024 FOLLOW-UP VIA E-MAIL: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSS ACTION. THE CONSUMER'S MOUTH RECOVERED. NO MEDICAL PROFESSIONAL WAS CONTACTED. NO SERIOUS INJURY WAS REPORTED. 23-OCT-2024 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSS ACTION EB50. NO SERIOUS INJURY WAS REPORTED. 24-OCT-2024 FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 62-YEAR-OLD MALE WHO ALSO REPORTED THAT HIS LIP AND INSIDE CHEEK OF HIS MOUTH WAS CUT BUT IMPROVED. NO SERIOUS INJURY WAS REPORTED. 06-DEC-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 SERIOUS INJURY WAS REPORTED.
LIP BLEED [LIP HEMORRHAGE]. CATCHES, NIP, CUTS - LIPS [LIP INJURY]. CATCHES, NIP, CUTS - MOUTH, INSIDE CHEEK [MOUTH INJURY]. CATCHES, NIP - TONGUE [TONGUE INJURY]. PAINFUL / SORE MOUTH, CHEEK [ORAL PAIN]. PAINFUL / SORE - TONGUE [GLOSSODYNIA]. PAINFUL / SORE - LIP [LIP PAIN]. HEAD OF MY TOOTHBRUSH HAS BECOME LOOSE - ORAL-B [DEVICE CONNECTION ISSUE]. CASE NARRATIVE: CONSUMER VIA E-MAIL REPORTED THAT THE ORAL-B TOOTHBRUSH HEAD BECAME LOOSE AND CAUGHT THEIR CHEEK, LIP, AND TONGUE GIVING THEM A NIP WHICH WAS PAINFUL AND MADE THEIR LIP BLEED. NO SERIOUS INJURY WAS REPORTED. 19-OCT-2024 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT LOT WAS 1047786000. NO SERIOUS INJURY WAS REPORTED. 22-OCT-2024 FOLLOW-UP VIA E-MAIL: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSS ACTION. THE CONSUMER'S MOUTH RECOVERED. NO MEDICAL PROFESSIONAL WAS CONTACTED. NO SERIOUS INJURY WAS REPORTED. 23-OCT-2024 FOLLOW-UP VIA IMAGE: THE SUSPECT PRODUCT WAS ORAL-B POWER ORAL CARE REFILLS CROSS ACTION EB50. NO SERIOUS INJURY WAS REPORTED. 24-OCT-2024 FOLLOW-UP VIA DIGITAL SAFETY ASSESSMENT SURVEY: THE CONSUMER WAS A 62-YEAR-OLD MALE WHO ALSO REPORTED THAT HIS LIP AND INSIDE CHEEK OF HIS MOUTH WAS CUT BUT IMPROVED. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2596075 | ORALBPWRORALCARERFLSCROSSACTNEB50 | TOOTHBRUSH, POWERED - JEQ | JEQ | BRAUN GMBH WERK MARKTHEIDENFELD | EB50 | 1047786000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN (A| ORALBRCHGTOOTHBRUSHHANDLE (ORAL-B/RECHARGEABLE TOO |