MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for SURGIMESH WN T1415-8 manufactured by Aspide Medical.
[25626016]
On (b)(6) 2014 the patient had an open ventral hernia repair using two pieces of surgimesh wn t1415-8. Approximately a month p. O. The patients skin wound from the ventral hernia repair broke down. On (b)(6) 2014 the patients wound was irrigated, debrided and re-closed. The patient was given antibiotics on (b)(6) 2014 the patients wound was again irrigated, debrided and a wound vac placed. On (b)(6) 2015 the patients abdominal wound was making progress and there was evidence of granulation taking place. At a (b)(6) 2015 check-up the patients abdominal wound was continuing to heal, a bit slowly. On (b)(6) 2015 the patient was brought to the surgeons office for excision of unincorporated t1415-8, irrigation of the site and debridements. By (b)(6) 2015 the patient called indicating that drainage had increased. On (b)(6) 2015 the surgeon excised the remaining t1415-8 and closed the patients abdominal wall. The sterility and acceptability for clinical use of the surgimesh wn t1415-8 was confirmed through the manufacturer lot history records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005841068-2015-00011 |
| MDR Report Key | 5070411 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-08-10 |
| Date Facility Aware | 2015-08-10 |
| Report Date | 2015-09-05 |
| Date Reported to FDA | 2015-09-05 |
| Date Reported to Mfgr | 2015-09-05 |
| Date Added to Maude | 2015-09-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 20925 PHEASANT TRAIL SUITE 100 |
| Manufacturer City | DEER PARK IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer G1 | BG MEDICAL LLC |
| Manufacturer Street | 20925 PHEASANT TRAIL SUITE 100 |
| Manufacturer City | DEER PARK IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGIMESH WN |
| Generic Name | T1415-8 |
| Product Code | OXJ |
| Date Received | 2015-09-09 |
| Model Number | T1415-8 |
| Catalog Number | T1415-8 |
| Lot Number | F08899A |
| Device Expiration Date | 2018-08-31 |
| Device Availability | N |
| Device Age | 11 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIDE MEDICAL |
| Manufacturer Address | 246 ALLEE LAVOISTER LA TALAUDIERE 42350 FR 42350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-09 |