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 2018-01-05 for COSEAL 934075 manufactured by Baxter Healthcare - Hayward.
[96461868]
(b)(6). 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
[96461869]
A patient experienced a post operative infection after undergoing an unspecified gynecological surgery in which coseal was used. The coseal was applied laparoscopically with a duplospray machine (no further detail was provided regarding the surgical technique). Subsequently, on an unknown date, the patient developed a postoperative infection (not further specified). Treatment for the event and clinical risk factors for increased infection risk were unknown. No further detail was provided regarding the patient? S outcome from the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-00006 |
| MDR Report Key | 7167283 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-05 |
| Date of Report | 2018-01-05 |
| Date Mfgr Received | 2017-12-11 |
| Date Added to Maude | 2018-01-05 |
| 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 |
| 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 | 2018-01-05 |
| Model Number | NA |
| Catalog Number | 934075 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2018-01-05 |