MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-27 for STRATAFIX SXPD2B405 manufactured by Surgical Specialties Corporation.
[140000341]
To date the complaint device has not been returned to surgical specialties corporation for root cause analysis. The lot number was not provided which precludes a dhr review from being performed at this time. Without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, patient? S pre-existing health conditions/allergies, post-operative instructions or events that may have occurred and/or contributed to the report wound dehiscence a definitive root cause cannot be determined at this time.
Patient Sequence No: 1, Text Type: N, H10
[140000342]
It was reported by the sales representative a doctor reported three (3) cases of wound dehiscence one (1) week post-op. The surgeon used stratafix in the subcutaneous and deep tissue layers. Second surgeries were performed. The status of the patients is not known and device sutures are not being returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00010 |
| MDR Report Key | 8455802 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-13 |
| Date Facility Aware | 2019-03-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Mfgr Received | 2005-01-14 |
| Date Added to Maude | 2019-03-27 |
| 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 | MR. RONALD GIANNANGELO |
| Manufacturer Street | 247 STATION DRIVE SUITE NE1 |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| 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 | 2019-03-27 |
| Model Number | SXPD2B405 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Address | RD. 495 MONTANA INDUSTRIAL PK AGUADILLA PR 00605 US 00605 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-27 |