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 Bg Medical.
[24231705]
On (b)(6) 2015 patient had an open ventral hernia repair and post operatively showed no bowel movement with tachycardia and abdominal pain. A ct scan showed a fluid collection behind the abdominal wall. The fluid collection was drained on (b)(6) 2015 showing purulent material and the patient was started on organism specific antibiotics. The xb tintra e-2226 was confirmed sterile through review of manufacturer sterilization records. On (b)(6) 2015 a follow-up ct scan showed no further fluid collection behind the abdominal wall. The patient was ambulating by (b)(6) 2015 and discharged with their drain in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005841068-2015-00006 |
| MDR Report Key | 5032731 |
| Date Received | 2015-08-21 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-05-06 |
| 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 | F009288A |
| 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 | BG MEDICAL |
| Manufacturer Address | 101 S. HOUGH ST. - #6A BARRINGTON IL 60010 US 60010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-21 |