FDA Adverse Event
Malfunction
Summary report: N
BARD PARKER
MDR report key: 3012595
·
Received February 21, 2013
Report
- Report Number
- 1836161-2013-00085
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- October 15, 2012
- Report Date
- February 21, 2013
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DUE TO A RECENT FDA INSPECTION THIS MDR IS BEING REPORTED LATE AS A RESULT OF A RE-EVALUATION.
Description of Event or Problem · 1
THE #11 BLADE SNAPPED IN HALF IN TWO PACKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77377 | BARD PARKER | CARBON RIB BACK #11 | GES | ASPEN SURGICAL PRODUCTS, INC. | 0004065 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |