FDA Adverse Event
Malfunction
Summary report: N
DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX)
MDR report key: 5964831
·
Received September 20, 2016
Report
- Report Number
- 1836161-2016-00092
- Event Type
- Malfunction
- Date Received
- September 20, 2016
- Date of Event
- August 8, 2016
- Report Date
- August 24, 2016
- Manufacturer
- ASPEN SURGICAL PRODUCTS, CALEDONIA
- Product Code
- OCT
- PMA / PMN Number
- K932449
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED ON (B)(6) THAT 2 PCS HAD A PACKAGING FAILURE. PRODUCT IN THE SEAL OF THE PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 616839 | DR FOG TREATED SPONGE, STERILE (40 EACH/ BOX) | DR. FOG | OCT | ASPEN SURGICAL PRODUCTS, CALEDONIA | DF-3120 | 100735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |