FDA Adverse Event
Malfunction
Summary report: N
BARD PARKER
MDR report key: 4862510
·
Received June 18, 2015
Report
- Report Number
- 1836161-2015-00056
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Date of Event
- March 6, 2015
- Report Date
- June 18, 2015
- Manufacturer
- ASPEN SURGICAL PRODUCTS, INC.
- Product Code
- GES
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED: THE CUSTOMER FOUND PIN HOLES IN THE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398696 | BARD PARKER | CARBON RIB-BACK BLADES SIZE 10, STER | GES | ASPEN SURGICAL PRODUCTS, INC. | 371110 | 0049118 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |