FDA Adverse Event
Injury
Summary report: N
ZEPF
MDR report key: 4604324
·
Received March 9, 2015
Report
- Report Number
- MW5041425
- Event Type
- Injury
- Date Received
- March 9, 2015
- Date of Event
- March 3, 2015
- Report Date
- March 9, 2015
- Manufacturer
- GEBRUDER ZEPF
- Product Code
- HAD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
KERRISON#3 WAS USED DURING A SPINAL CASE. THE KERRISON WAS ATTACHED TO DURA TISSUE AND WOULD NOT RELEASE. THE DURA TISSUE HAD TO BE CUT AWAY FROM THE KERRISON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 160430 | ZEPF | KERRISON #3 | HAD | GEBRUDER ZEPF | 52-400-00B/52-482-03 EB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |