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 2019-03-06 for STRATAFIX SXMD1B105 manufactured by Surgical Specialties Corporation.
[137973796]
To date the samples have not been received by surgical specialties corporation for root cause and failure analysis. To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of wound dehiscence, a definitive root cause cannot be determined at this time. When and if additional information is received a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137973797]
Out affiliate is reporting a patient returned to the surgeon with a case of dehiscence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00009 |
| MDR Report Key | 8394841 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-06 |
| Date of Report | 2019-06-05 |
| 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 |
| Device Manufacturer Date | 2017-05-01 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Manufacturer G1 | SURGICAL SPECIALTIES CORPORATION |
| Manufacturer Street | RD 495 MONTANA INDUSRIAL PARK |
| 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 | MONODERM |
| Product Code | GAB |
| Date Received | 2019-03-06 |
| Model Number | SXMD1B105 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-03-06 |