FDA Adverse Event
Injury
Summary report: N
TEMP PUMP TEMPERATURE
MDR report key: 2743278
·
Received September 6, 2012
Report
- Report Number
- 1313850-2012-00282
- Event Type
- Injury
- Date Received
- September 6, 2012
- Date of Event
- August 7, 2012
- Report Date
- August 7, 2012
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- DWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT A LAB-MIX DOG HAD DEVELOPED A THERMAL BURN 18 DAYS AFTER DENTAL PROCEDURE WAS PERFORMED. TP500 (B)(4) WAS USED AT 107F WITH SHEET BETWEEN PATIENT AND PAD. THE PAD WAS A CINCINNATI SUB-ZERO REUSABLE HEAVY DUTY PAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMP PUMP TEMPERATURE | TEMPERATURE PUMP | DWJ | STRYKER CORP DBA GAYMAR | TP500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |