FDA Adverse Event
Malfunction
Summary report: N
PADGETT ELECTRO-DERMATOME MODEL B 110 V
MDR report key: 912969
·
Received September 14, 2007
Report
- Report Number
- 3003418325-2007-00013
- Event Type
- Malfunction
- Date Received
- September 14, 2007
- Report Date
- September 14, 2007
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- GFD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO INTEGRA LIFESCIENCES CORPORATION.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE DEVICE WAS GRINDING AND BURNING THE SKIN. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PADGETT ELECTRO-DERMATOME MODEL B 110 V | DERMATOME | GFD | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |