MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-24 for BIODESIGN HERNIA GRAFT G48216 C-SLH-8H-20X30 manufactured by Cook Biotech.
[98123825]
A review of the device lot history records indicated the device was manufactured to specifications. The deviation would not have contributed to the reported occurrence. A total of two (2) devices was produced from the lot. A review of the cbi complaint database did not reveal any additional complaints involving the reported lot number. A review of the ifu indicated that seroma formation and infection (irrespective of one another) are noted in the potential complications as some of the "possible adverse reactions with the use of any prosthesis. " in addition, the ifu notes that? Complications, such as delayed wound infection, premature degradation, hernia recurrence, bowel erosion, and the need for re-operation, should be reasonably expected in patients who are critically ill or who have severely contaminated abdomens. " the root cause of the seroma is likely related to the extensive disruption of tissue that occurred during the surgical procedure. However, seroma formation is a known inherent risk of the surgical procedure and is a known potential outcome with the use of any prosthesis.
Patient Sequence No: 1, Text Type: N, H10
[98123826]
On (b)(6) 2017, dr. (b)(6) placed a c-slh-8h-20x30 in a (b)(6) male patient. The patient had a prior placement of polypropylene mesh which became infected. The infected polypropylene was removed by laparoscopy and the biodesign hernia graft was placed in an open procedure. The biodesign was placed for repair of a ventral hernia. Seroma fluid was drained for approximately 28-30 days. The patient was discharged from the hospital once the drain output was below 20 ml per day. Two (2) weeks later, approximately fifty (50) days post biodesign placement, the patient was admitted to the hospital due to fever and seroma formation. The seroma was unable to be drained due to thickness and the patient underwent additional surgery to assess for infection and seroma. The seroma was described as thick, 300 ml fluid collection, and a cause was unable to be found. A tissue specimen was sent for laboratory review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1835959-2018-00002 |
| MDR Report Key | 7214926 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-01-24 |
| Date of Report | 2018-02-12 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2018-01-24 |
| 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 |
| 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 | 2018-01-24 |
| Model Number | G48216 |
| Catalog Number | C-SLH-8H-20X30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-01-24 |