MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-17 for SURGIMESH SURGIMESH XB TINTRA E-2226 manufactured by Aspide Medical.
[25132452]
Patient returned to the surgeon after gaining (b)(6) since prior hernia repair on (b)(6) 2013, w/signs of bowel obstruction and what looked to be a lateral recurrence. On (b)(6) 2015, the previously placed surgimesh xb tintral e-2226 was removed and replaced w/an xb tintra e-3030 w/out consequence. The xb e-2226 showed no signs of failure except that the fixation tacks had pulled out of the abdominal wall tissue in places. The patient recovered uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005841068-2015-00009 |
| MDR Report Key | 5057543 |
| Date Received | 2015-08-17 |
| Date of Report | 2015-08-15 |
| Date of Event | 2015-07-23 |
| Date Facility Aware | 2015-07-23 |
| Report Date | 2015-08-15 |
| Date Reported to Mfgr | 2015-08-15 |
| Date Added to Maude | 2015-09-04 |
| 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 |
| Product Code | OXJ |
| Date Received | 2015-08-17 |
| Model Number | SURGIMESH XB |
| Catalog Number | TINTRA E-2226 |
| Lot Number | FO6298A |
| Device Expiration Date | 2017-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 22 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPIDE MEDICAL |
| Manufacturer Address | 246 ALLEE LAVOISIER LA TALAUDIERE 42350 FR 42350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-17 |