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 2019-06-05 for STRATAFIX SXPD2B404 manufactured by Surgical Specialties Corporation.
| Report Number | 3010692967-2019-00017 |
| MDR Report Key | 8670241 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-05 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-05-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2019-06-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RONALD GIANNANGELO |
| Manufacturer Street | 247 STATION DRIVE SUITE NE1 |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Manufacturer G1 | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Street | RD 495 MONTANA INDUSRIAL PARK EJIDO FRANCISCO VILLA |
| Manufacturer City | AGUADILLA PR 00605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRATAFIX |
| Generic Name | STRAFIX PDO |
| Product Code | GAB |
| Date Received | 2019-06-05 |
| Model Number | SXPD2B404 |
| Lot Number | AABD401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Address | CORREDOR TIJUANA ROSARITO 2000 #24702 B, EJIDO FRANCISCO VILL TIJUANA PR 22235 US 22235 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-05 |