MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-28 for INTEGUSEAL * 33737 manufactured by Halyard (lab), Formerly Known As Kimberly Clark.
[5578672]
Ten packages of integuseal tissue sealant were found on the shelf with black mold in inner packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4643398 |
| MDR Report Key | 4643398 |
| Date Received | 2015-01-28 |
| Date of Report | 2015-01-28 |
| Date of Event | 2015-01-22 |
| Report Date | 2015-01-28 |
| Date Reported to FDA | 2015-01-28 |
| Date Reported to Mfgr | 2015-03-31 |
| Date Added to Maude | 2015-03-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGUSEAL |
| Generic Name | SEALANT, MICROBIAL |
| Product Code | NZP |
| Date Received | 2015-01-28 |
| Model Number | * |
| Catalog Number | 33737 |
| Lot Number | P00018382 |
| ID Number | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD (LAB), FORMERLY KNOWN AS KIMBERLY CLARK |
| Manufacturer Address | 15440 LAGUNA CANYON RD SUITE 1 IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-28 |