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 2016-09-07 for COSEAL 934075 manufactured by Baxter Healthcare - Hayward.
[54138352]
Complaint no: (b)(4). 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
[54138353]
A patient experienced an anaphylactic reaction four minutes post application of coseal during a surgical procedure. The patient had undergone a bariatric procedure (removal of a lap band) in which coseal was used (no further detail was provided regarding the surgical technique). Subsequently, at the end of the surgical case during reversal of the general anesthesia (unspecified) with an unknown agent, the patient experienced tachycardia, a significant drop in blood pressure (not further specified), and a skin rash (location was not reported). The reaction occurred after surgical closure on wake up. The coseal was not removed. It was reported that adrenaline was administered (dose not reported) and the patient responded and was transferred to the intensive care unit with an uneventful recovery. No further information 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 | 1416980-2016-12502 |
| MDR Report Key | 5934721 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-07 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-05-09 |
| Date Mfgr Received | 2016-05-10 |
| Date Added to Maude | 2016-09-07 |
| 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 Contact | KINGA ALMASAN |
| 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 | 2016-09-07 |
| Catalog Number | 934075 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | 2024 W WINTON AVE HAYWARD CA 94545 US 94545 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-09-07 |