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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH SURGISIS

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COOK BIOTECH SURGISIS Back to Search Results
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 small bowel obstruction with mesenteric herniation through 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. Six months post transplant the patient had a small bowel obstruction with mesenteric herniation through the surgisis.
 
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Brand NameSURGISIS
Manufacturer (Section D)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
nick wang
MDR Report Key11002588
MDR Text Key221250558
Report Number1835959-2020-00004
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
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 Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2020
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 Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
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