MAUDE Adverse Event Report: COOK BIOTECH SURGISIS

Catalog Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

Date of event not reported; date of study was september 2006 - december 2018 device common name unknown as the authors only reported the device as "surgisis".No specific device model information was provided.Device product code unknown as the authors only reported the device as "surgisis".No specific device model information was provided.The device was used in an intraperitoneal fashion.Device model unknown as the authors only reported the device as "surgisis".No specific device information was provided.Device lot number was not provided.Device expiration date is unknown as the lot number was not provided.Implant date was not reported by the authors.The date of the study was september 2006 - december 2018.Device 510k is unknown as the authors only reported the device as "surgisis".No specific device model information was provided.The device manufacture date is unknown as the authors did not provide a lot number.Investigation into this feedback included a review of the publication.The root cause of the occurrence is inconclusive.Many factors may have contributed to the occurrence, including, but not limited to, user technique, graft not having maximum possible contact with healthy, well-vascularized tissue, and the complexity / severity of the patient's underlying condition.

Event Description

This complaint is to capture the occurrence of a bowel obstruction with herniation through defect at edge of surgisis which required surgical correction.The overall details of the publication are captured in a separate complaint.The source of the publication is doi: 10.1111/petr.13935 complications of surgical mesh patches after kidney transplantation in children - a case series.An unspecified surgisis graft was used in a (b)(6) year old patient that underwent single kidney transplant.The authors reported that "abdominal compartment syndrome after kidney transplantation in pediatric recipients is a recognized complication relating to size discrepancy requiring abdominal wall closure over a large adult allograft.In order to circumvent this problem, our center implemented use of a surgical mesh, surgisis, for abdominal wall closure in very small children to increase the surface covering over the organ and prevent compression." details of the surgical procedure, placement of the graft, and other surgical details were not provided.One month post transplant the patient had a small bowel obstruction with herniation through defect at edge of surgisis.

• Brand Name: SURGISIS
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: nick wang
• MDR Report Key: 11002572
• MDR Text Key: 221248874
• Report Number: 1835959-2020-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR