FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD BASE UNIT
MDR report key: 908932
·
Received September 7, 2007
Report
- Report Number
- 3004608878-2007-00021
- Event Type
- Malfunction
- Date Received
- September 7, 2007
- Report Date
- September 7, 2007
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 SLIPPED DURING A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD BASE UNIT | OPERATING ROOM TABLE ACCESSORY | HBL | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |