MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-04 for FINE SURGICAL 12-201 manufactured by Crown Surgical Corp..
| Report Number | 1047429-2020-00001 |
| MDR Report Key | 9668996 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-02-04 |
| 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. NICHOLE EARLY |
| Manufacturer Street | 9000 WESTMONT DR. STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal | 23168 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | AVID MEDICAL, INC. |
| Manufacturer Street | 9000 WESTMONT DRIVE STONEHOUSE COMMERCE PARK |
| Manufacturer City | TOANO VA 23168 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23168 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINE SURGICAL |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2020-02-04 |
| Model Number | 12-201 |
| Lot Number | P729028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROWN SURGICAL CORP. |
| Manufacturer Address | 16/18-C NISHTAR ROAD S-I-E FACTORY AREA SIALKOT PUNJAB, PK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |