MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for SURGIMESH XB TINTRA E-2226 manufactured by Aspide Medical.
[24222857]
Following removal of previously placed mesh and re-repair of a ventral hernia using surgimesh xb e-2226 during a robotic laparoscopic, the patient was diagnosed with pneumoperitoneum on (b)(6) 2015. At re-exploration the patient was found to have a transverse colon enterotomy which was repaired and treated with cipro/flagyl and a wound vac. On pod 3 the patient was taken back to the operating room for an i and d with intermediate closure performed. On pod 8 the patients wound vac was taken down and the abdominal wound packed with aquacel and covered with gauze. On pod 9 the patient was transferred to the sar where her vital signs were stable. Wound treatment continues with the xb e-2226 in place. Sterility of the xb e-2226 was confirmed with the manufacturers sterilization records.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005841068-2015-00008 |
| MDR Report Key | 5032733 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-04-30 |
| Date Facility Aware | 2015-07-22 |
| Report Date | 2015-08-18 |
| Date Reported to Mfgr | 2015-08-18 |
| Date Added to Maude | 2015-08-26 |
| 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-2226 |
| Product Code | OXJ |
| Date Received | 2015-08-21 |
| Model Number | TINTRA E-2226 |
| Catalog Number | TINTRA E-2226 |
| Lot Number | F09288A |
| Device Expiration Date | 2019-03-28 |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIDE MEDICAL |
| Manufacturer Address | 246 ALLEE LAVOISIER LATALAUDIERE 42350 FR 42350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-21 |