FDA Adverse Event
Malfunction
Summary report: N
INTEGUSEAL
MDR report key: 4643398
·
Received January 28, 2015
Report
- Report Number
- 4643398
- Event Type
- Malfunction
- Date Received
- January 28, 2015
- Date of Event
- January 22, 2015
- Report Date
- January 28, 2015
- Manufacturer
- HALYARD (LAB), FORMERLY KNOWN AS KIMBERLY CLARK
- Product Code
- NZP
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Narratives
Description of Event or Problem · 1
TEN PACKAGES OF INTEGUSEAL TISSUE SEALANT WERE FOUND ON THE SHELF WITH BLACK MOLD IN INNER PACKAGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65286 | INTEGUSEAL | SEALANT, MICROBIAL | NZP | HALYARD (LAB), FORMERLY KNOWN AS KIMBERLY CLARK | * | P00018382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |