MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for SURGIMESH XB TINTRA E-1522 manufactured by Aspide Medical.
[25627318]
Patient had an open ventral hernia repair on (b)(6) 2015 with surgimesh xb tintra e-1522. The abdominal wall incision never healed and opened up. On (b)(6) 2015 another doctor at the (b)(6) medical center did an open exploratory laparoptomy to debried and irrigate the wound in an attempt to clear up the infection. On (b)(6) 2015 a second and third open exploratory laparotomy was performed to irrigate and debried the wound. During the final irrigation and debriedment the tintra e-1522 was removed. Per hospital policy the tintra e-1522 was kept at the hospital and finally disposed of. The sterility and acceptability for clinical use of the surgimesh xb tintra e-1522 was confirmed through the manufacturer lot history records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005841068-2015-00010 |
| MDR Report Key | 5070407 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-08-31 |
| Date of Event | 2015-08-10 |
| Date Facility Aware | 2015-08-10 |
| Report Date | 2015-09-04 |
| Date Reported to FDA | 2015-09-04 |
| Date Reported to Mfgr | 2015-09-04 |
| 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 XB |
| Generic Name | TINTRA E-1522 |
| Product Code | OXJ |
| Date Received | 2015-09-09 |
| Model Number | TINTRA E-1522 |
| Catalog Number | TINTRA E-1522 |
| Lot Number | F08761A |
| Device Expiration Date | 2018-10-26 |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIDE MEDICAL |
| Manufacturer Address | 246 ALLEE LAVOISIER LA TALAUDIERIE 42350 FR 42350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-09 |