FDA Adverse Event
Injury
Summary report: N
S-12
MDR report key: 8295675
·
Received February 1, 2019
Report
- Report Number
- 9681479-2019-00001
- Event Type
- Injury
- Date Received
- February 1, 2019
- Date of Event
- January 4, 2019
- Report Date
- January 22, 2019
- Manufacturer
- W&H DENTALWERK BUERMOOS GMBH
- Product Code
- KMW
- UDI-DI
- J021300610001
- PMA / PMN Number
- K080939
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS ANALYSED IN W&H SERVICE STATION. THERE WERE NO DAMAGES IDENTIFIED. IT FUNCTIONS ACCORDINGLY DURING THE TEST PROCEDURE.
Description of Event or Problem · 1
THE END-USER STATED THAT THE TIP OF THE HANDPIECE S-12 GOT HOT AND BURNED THE PATIENT. ALSO THE ASSISTANT GOT BURN MARKS AFTER TOUCHING THE HANDPIECE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89244 | S-12 | SURGICAL HANDPIECE | KMW | W&H DENTALWERK BUERMOOS GMBH | S-12 | J021300610001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |