FDA Adverse Event
Malfunction
Summary report: N
BARD PARKER DISPOSABLE SCALPELS
MDR report key: 3012658
·
Received February 22, 2013
Report
- Report Number
- 1836161-2013-00096
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 22, 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 AS A RESULT OF A RE-EVALUATION.
Description of Event or Problem · 1
THE SCALPEL BLADE IS COMING BROKEN AT THE AREA OF THE BLADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78768 | BARD PARKER DISPOSABLE SCALPELS | SCALPEL, SURGICAL | GES | ASPEN SURGICAL PRODUCTS, INC. | 0017655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |