MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for FLOSEAL manufactured by Baxter Healthcare Corporation.
[179295942]
Spike on floseal failed to properly pierce vial, requiring the spike to be adjusted in order for spike to pierce vial.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092940 |
| MDR Report Key | 9699711 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOSEAL |
| Generic Name | AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED |
| Product Code | LMF |
| Date Received | 2020-02-11 |
| Lot Number | HA191284A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |