MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-05 for BIODESIGN HERNIA GRAFT G36033 C-SLH-8H-20X20 manufactured by Cook Biotech.
[113245347]
Date of event not provided by the complainant. Lot number not provided by the complainant. Implant date not provided by the complainant. A review of the device lot history records indicated that the device was manufactured to specifications. A total of two devices was produced from the lot. A review of the cbi complaint database revealed no additional complaints involving the reported lot number. Adhesion is noted amongst the list of potential complications provided in the ifu. The root cause, of the reported device adhesion to the small bowel, is inconclusive at this time. A specimen was returned to cbi and will be sent for histopathology testing. A follow-up mdr and root cause summary will be documented once results of the histopathology testing are received.
Patient Sequence No: 1, Text Type: N, H10
[113245348]
In (b)(6) 2015, dr. (b)(6) placed a biodesign hernia graft for repair of an incisional hernia. In 2018, the patient was seen for complaints of pain. Dr. (b)(6) reoperated and found the device adhered to the small bowel, not incorporated, and crumpled. The device was reportedly explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2018-00009 |
| MDR Report Key | 7664320 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-05 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-09-03 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2018-07-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 Contact | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Manufacturer G1 | COOK BIOTECH INCORPORATED |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIODESIGN HERNIA GRAFT |
| Generic Name | HERNIA GRAFT |
| Product Code | OXK |
| Date Received | 2018-07-05 |
| Returned To Mfg | 2018-07-03 |
| Model Number | G36033 |
| Catalog Number | C-SLH-8H-20X20 |
| Lot Number | LB763019 |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-05 |