MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for INTEGUSEAL manufactured by Halyard (lab) Irvine.
[40909609]
Patient Sequence No: 1, Text Type: N, H10
[40909610]
Before opening the package of integuseal, it was noticed the device was already activated due to the liquid in the package. No patients were affected. A new package was used from the same lot number and was fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5517531 |
| MDR Report Key | 5517531 |
| Date Received | 2016-03-22 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-10-31 |
| Report Date | 2015-11-05 |
| Date Reported to FDA | 2015-11-05 |
| Date Reported to Mfgr | 2015-11-05 |
| Date Added to Maude | 2016-03-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGUSEAL |
| Generic Name | SEALANT, MICROBIAL |
| Product Code | NZP |
| Date Received | 2016-03-22 |
| Lot Number | P00203417 |
| Device Expiration Date | 2017-06-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD (LAB) IRVINE |
| Manufacturer Address | 15440 LAGUNA CANYON RD SUITE 130 ROSWELL CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |