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 2019-05-14 for STRATAFIX SXMD1B406 manufactured by Surgical Specialties Corporation.
[144969433]
To date no samples have been received by surgical specialties corporation for root cause and failure analysis. Without reviewing and testing the actual device or receiving details of what was observed upon return of the patient and/or what type of intervention was required a definitive root cause cannot be determined at this time. A review of the device history records for the finished good lots, did not identify any quality issues during the incoming, manufacturing, in-process or final inspection processes. There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria. When and if additional information is received a follow-up report will be filed. There were no other complaints received of any kind for the reported lot number.
Patient Sequence No: 1, Text Type: N, H10
[144969434]
It was reported the patient had laparoscopic right hernioplasty on (b)(6) 2019. Patient was discharged after 4 days. On (b)(6) the patient was sick and in pain. Ct report indicated that volvulus was observed. It was found end of the suture adhered jejunal mesentery and physician figured it out. The patient is doing better and was discharged on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00016 |
| MDR Report Key | 8607776 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-09 |
| Date Facility Aware | 2019-04-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2019-04-29 |
| Date Mfgr Received | 2005-01-14 |
| Device Manufacturer Date | 2017-04-23 |
| Date Added to Maude | 2019-05-14 |
| 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 | 2019-05-14 |
| Model Number | SXMD1B406 |
| Lot Number | MDVR760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| 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 | 2019-05-14 |