MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-01 for COSEAL 934075 manufactured by Baxter Healthcare - Hayward.
[58842270]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[58842271]
A patient experienced abdominal pain five days after an unspecified surgery in which coseal was used. The patient was taken back to surgery and a large portion of pus was present in the area where coseal had been previously applied. On an unreported date, the patient was treated with unspecified antibiotics for the event. The patient's outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[61636283]
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2016-16833 |
| MDR Report Key | 6069191 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-01 |
| Date of Report | 2016-12-07 |
| Date Mfgr Received | 2016-11-18 |
| Date Added to Maude | 2016-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Street | 2024 W WINTON AVE NI |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COSEAL |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2016-11-01 |
| Model Number | NA |
| Catalog Number | 934075 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | HAYWARD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-11-01 |