MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-06 for TISSEEL manufactured by Baxter.
[673256]
Per circulating nurse - attempted to mix tisseel -in cranioplasty case-. First batch would not mix. Attempted second batch, but it would not mix. Called nearby hospital to get more tisseel. The first batch finally mixed after one hour.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5003345 |
| MDR Report Key | 891751 |
| Date Received | 2007-08-06 |
| Date of Report | 2007-08-06 |
| Date of Event | 2007-07-30 |
| Date Added to Maude | 2007-08-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSEEL |
| Generic Name | FIBRIN SEALANT |
| Product Code | MZM |
| Date Received | 2007-08-06 |
| Returned To Mfg | 2007-07-31 |
| Lot Number | 06L01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873034 |
| Manufacturer | BAXTER |
| Manufacturer Address | 1627 LAKE COOK ROAD DEERFIELD IL 60015 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-06 |