FDA Adverse Event
Malfunction
Summary report: N
MAYFIELD MODIFIED SKULL CLAMP
MDR report key: 1191133
·
Received September 26, 2008
Report
- Report Number
- 3004608878-2008-00080
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Report Date
- September 26, 2008
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- HBL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem · 1
THE USER FACILITY REPORTED THAT THE DEVICE DID COME IN CONTACT WITH A PT. THE PT SUSTAINED A LACERATION. REQUESTED ADD'L INFO FROM THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAYFIELD MODIFIED SKULL CLAMP | NONE | HBL | INTEGRA LIFESCIENCES CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |