FDA Adverse Event
Malfunction
Summary report: N
DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX)
MDR report key: 5220549
·
Received November 12, 2015
Report
- Report Number
- 1836161-2015-00088
- Event Type
- Malfunction
- Date Received
- November 12, 2015
- Date of Event
- August 12, 2015
- Report Date
- October 13, 2015
- Manufacturer
- ASPEN SURGICAL PRODUCTS, CALEDONIA
- Product Code
- OCT
- PMA / PMN Number
- PK932449
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REJECTED 1 PIECE DUE TO PACKING FAILURE. PRODUCT IS IN SEAL OF PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 750699 | DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX) | DR FOG TREATED SPONGE | OCT | ASPEN SURGICAL PRODUCTS, CALEDONIA | DF-3120 | 71266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |