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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES

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COOK BIOTECH BIODESIGN 4-LAYER TISSUE GRAFT SURGISIS ES Back to Search Results
Catalog Number C-SLH-4S-4X7
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Date of event not provided by the complainant. Related to (b)(4). A review of the device lot history records indicated the device was manufactured to specifications. A total of (b)(4) devices were produced from the lot. A review of the cbi complaint database revealed no additional complaints involving the reported lot number. A review of the ifu indicated that infection, acute or chronic inflammation and allergic reaction were noted as potential complications. Further follow-up from the cook area representative indicated that the surgeon retired in 2011. A direct root cause, of the incident described in (b)(4), is inconclusive due to a lack of details available. The implant date was noted as (b)(6) 2003. It is important to note that the biodesign or surgisis es soft tissue graft is biologic in nature and is resorbed and replaced with natural tissue in a few months post-implantation, leaving nothing behind. In fact, our product was often used to repair the failure of synthetic meshes. Although a direct root cause is inconclusive, the patient¿s reported long term effects are not likely related to the use of the biodesign or surgisis soft tissue graft due to the resorbtion properties of the surgisis. Many factors could contribute to the patient¿s reported outcome, including, but not limited to, surgical technique, positioning of the patient while on the operating table, underlying patient conditions, and the patient¿s post-operative care activities.
 
Event Description
(b)(4). The complainant reported being implanted with a j-slh-4s-4x7, on (b)(6) 2003, for a posterior repair. The surgery took place at (b)(6) hospital and was performed by dr. (b)(6). The complainant reported experiencing severe chronic pain, perineal / buttock pain, exacerbated by walking, standing, and sitting, constipation, pain on micturation (urination), and the inability to have sexual intercourse.
 
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Brand NameBIODESIGN 4-LAYER TISSUE GRAFT
Type of DeviceSURGISIS ES
Manufacturer (Section D)
COOK BIOTECH
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
perry guinn
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key6900262
MDR Text Key87618828
Report Number1835959-2017-00006
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K980431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 09/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberC-SLH-4S-4X7
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/20/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/28/2017 Patient Sequence Number: 1
Treatment
NONE REPORTED BY THE COMPLAINANT.
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