FDA Adverse Event
Malfunction
Summary report: N
ORALBRCHGTOOTHBRUSHHANDLE3772PRO33900MODELD505.523.3H
MDR report key: 20004330
·
Received August 20, 2024
Report
- Report Number
- 3000302531-2024-00391
- Event Type
- Malfunction
- Date Received
- August 20, 2024
- Report Date
- August 16, 2024
- Manufacturer
- BRAUN GMBH WERK MARKTHEIDENFELD
- Product Code
- JEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PRODUCT RETURN WAS NOT RECEIVED. PRODUCT RETURN WAS REQUESTED. FULL EVALUATION WILL OCCUR UPON RECEIPT OF PRODUCT RETURN.
Description of Event or Problem · 0
METAL SHAFT HAS BROKEN...HEAD WAS OFF INSIDE MOUTH - ORAL-B [DEVICE BREAKAGE] CASE NARRATIVE: A MOTHER VIA PHONE STATED THAT THE METAL SHAFT ON HER DAUGHTER'S ORAL-B PRO 3 TOOTHBRUSH WAS BROKEN AND THE ORAL-B PRECISION CLEAN TOOTHBRUSH HEAD WAS OFF INSIDE HER MOUTH. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1066268 | ORALBRCHGTOOTHBRUSHHANDLE3772PRO33900MODELD505.523.3H | TOOTHBRUSH, POWERED - JEQ | JEQ | BRAUN GMBH WERK MARKTHEIDENFELD | D505.523.3H | 3CB22860237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | ORALBPWRORALCARERFLSPRECISIONCLEANANTIBAC (ORAL-B/ |