MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-21 for STATSEAL POWDER manufactured by Biolife, Llc.
| Report Number | 1066421-2019-00001 |
| MDR Report Key | 9356507 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-11-06 |
| Date Added to Maude | 2019-11-21 |
| 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 | MS CLAUDIA MASSELINK |
| Manufacturer Street | 8163 25TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal | 34243 |
| Manufacturer Phone | 9413601300 |
| Manufacturer G1 | BIOLIFE, LLC |
| Manufacturer Street | 8163 25TH COURT EAST |
| Manufacturer City | SARASOTA FL 34243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATSEAL POWDER |
| Generic Name | STATSEAL POWDER |
| Product Code | FRO |
| Date Received | 2019-11-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOLIFE, LLC |
| Manufacturer Address | 8163 25TH COURT EAST SARASOTA FL 342433424 US 342433424 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-21 |