FDA Adverse Event
Injury
Summary report: N
PHILIPSSONICARE
MDR report key: 11158054
·
Received January 12, 2021
Report
- Report Number
- 3026630-2021-00005
- Event Type
- Injury
- Date Received
- January 12, 2021
- Date of Event
- November 30, 2020
- Manufacturer
- PHILIPS ORAL HEALTHCARE, LLC
- Product Code
- JEQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
D4: THE PRODUCT MODEL WAS IDENTIFIED AND UPDATED. ANALYSIS RESULTS: FAILURE ANALYSIS OF THE RETURNED PRODUCT (PERFORMED AT PHILIPS ORAL HEALTHCARE) IDENTIFIED THAT THE ROOT CAUSE WAS A DEFORMED CHARGER DUE TO CUSTOMER MISUSE.
Additional Manufacturer Narrative · 1
THE EVENT DATE IS APPROXIMATE. THE PRODUCT MODEL, CATALOG NUMBER, SERIAL NUMBER, LOT NUMBER, AND UDI WERE NOT PROVIDED. A PARTIAL SERIAL NUMBER WAS DETERMINED FROM PHOTOS PROVIDED BY THE CONSUMER. REPORT SOURCE: THE COMPLAINT WAS RECEIVED FROM A CONSUMER IN (B)(6).
Description of Event or Problem · 1
A CONSUMER REPORTED THAT THEIR PHILIPS CHARGER CAUGHT FIRE. NO SERIOUS INJURIES OR PROPERTY DAMAGE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49741 | PHILIPSSONICARE | SONICARE CHARGER | JEQ | PHILIPS ORAL HEALTHCARE, LLC | 420303553940 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |