MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other,use report with the FDA on 2019-02-12 for STRATAFIX SXMD1B408 manufactured by Surgical Specialties Corporation.
[135881610]
On (b)(6) 2019 information was received regarding the re-suturing case. The patient had pre-existing scar tissue that's dented which impacted the stratafix. There was an area of infected tissue removed and cleaned prior to the re-suture. The surgeon stated the prineo was removed too early by the staff, there was moisture which rolled off. The surgeon stated the hospital staff was re-trained. There was insufficient closure leaving dead space. The surgeon stated the staff was re-trained. Since addressing these issues the surgeon reports the patient is doing fine. In addition, the patient was given antibiotics to resolve an infection which cultured & mixed anaerobes & staph aureus & granulicatella adiacens. Patient morbidities included type 2 diabetes, hypertension, hx cancer. 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 lot.
Patient Sequence No: 1, Text Type: N, H10
[135881611]
The initial procedure was on (b)(6) 2018. The patient returned to the surgeon with severe dehiscence as well as an infection. Bilateral wounds were still intact and looked good. The dehiscence looked to go down to fascia muscle. Large areas of the tissue had to be re-sutured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010692967-2019-00004 |
| MDR Report Key | 8331339 |
| Report Source | DISTRIBUTOR,FOREIGN,OTHER,USE |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-20 |
| Date of Event | 2018-11-06 |
| Date Facility Aware | 2018-11-27 |
| 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 | 2019-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| 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 SUTURE MONODERM |
| Product Code | GAB |
| Date Received | 2019-02-12 |
| Model Number | SXMD1B408 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-02-12 |