FDA Adverse Event
Malfunction
Summary report: N
ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE
MDR report key: 9716592
·
Received February 17, 2020
Report
- Report Number
- 1836161-2020-00010
- Event Type
- Malfunction
- Date Received
- February 17, 2020
- Date of Event
- January 23, 2020
- Report Date
- January 23, 2020
- Manufacturer
- ASPEN SURGICAL PRODUCTS, CALEDONIA
- Product Code
- FTA
- PMA / PMN Number
- K020304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181816 | ASPEN SURGICAL'S ALC PLUS DISPOSABLE LIGHT HANDLE COVER STERILE | LIGHT HANDLE | FTA | ASPEN SURGICAL PRODUCTS, CALEDONIA | LT-ALC01 | 202234 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |