FDA Adverse Event
Malfunction
Summary report: N
O.R. CAMERA COVER, STERILE
MDR report key: 5664874
·
Received May 18, 2016
Report
- Report Number
- 1836161-2016-00043
- Event Type
- Malfunction
- Date Received
- May 18, 2016
- Date of Event
- April 11, 2016
- Report Date
- April 19, 2016
- Manufacturer
- ASPEN SURGICAL PRODUCTS, CALEDONIA
- Product Code
- FTA
- PMA / PMN Number
- PK020304
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DESCRIPTION OF THE COMPLAINT IS,"PACKAGING NOT SEALED AT ONE END."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319874 | O.R. CAMERA COVER, STERILE | CAMERA COVER | FTA | ASPEN SURGICAL PRODUCTS, CALEDONIA | LT-C02 | 95769 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |