FDA Adverse Event
Malfunction
Summary report: N
ORALBPWRPWRORALCARERFLSCROSSACTNEB50BRUSHSET1CT
MDR report key: 13228253
·
Received January 11, 2022
Report
- Report Number
- 3000302531-2022-00016
- Event Type
- Malfunction
- Date Received
- January 11, 2022
- Report Date
- January 2, 2022
- Manufacturer
- BRAUN GMBH WERK MARKTHEIDENFELD
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT RETURN WAS REQUESTED BUT NOT RECEIVED SO FAR. FULL EVALUATION WILL OCCUR UPON RECEIPT OF RETURNED PRODUCT.
Description of Event or Problem · 0
(JABBED LIP) MADE IT BLEED [LIP HAEMORRHAGE]. JABBED LIP (MADE IT BLEED) [LIP INJURY]. TIP CAME OFF IN THE METAL PART (PARK) - ORAL-B [DEVICE BREAKAGE]. CONSUMER VIA E-MAIL STATED THAT, WHILE BRUSHING THEIR TEETH, THE TIP OF THE ORAL-B ELECTRIC TOOTHBRUSH CAME OFF IN THE METAL PART AND JABBED THEIR LIP, MAKING IT BLEED. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17822 | ORALBPWRPWRORALCARERFLSCROSSACTNEB50BRUSHSET1CT | TOOTHBRUSH, POWERED | JEQ | BRAUN GMBH WERK MARKTHEIDENFELD | EB50 | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | ORAL-B RECHARGEABLE TOOTHBRUSH, VERSION UNKNOWN |