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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-7X10
Device Problem Material Erosion (1214)
Patient Problems Abdominal Pain (1685); Erosion (1750); Fatigue (1849); Fever (1858); Headache (1880); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)
Event Date 04/09/2014
Event Type  Injury  
Manufacturer Narrative
Date of event not provided by the complainant. Lot number provided by the complainant was not a valid cbi lot number. Product expire date unknown; lot number not provided. Surgeon name not provided by the complainant. Product manufacture date unknown; lot number unknown. A review of the device lot number provided by the complainant revealed that it was not a valid lot number for a cook biotech incorporated manufactured device. Additionally, the gpn provided by the complainant was not a valid number for a cook biotech incorporated manufactured device. A review of the ifu revealed that infection, acute or chronic inflammation, allergic reaction, and seroma formation are noted as potential complications that are possible with the use of surgical graft materials. Based on the information provided by the complainant, details regarding a specific correlation between the biodesign surgisis tissue graft's performance and the alleged injury remain unknown. A root cause is inconclusive due to the lack of details provided by the complainant.
 
Event Description
(b)(6). The complainant reported being implanted with a c-slh-4s-7x10 g12563 lb588511 on (b)(6) 2013. The complainant reported experiencing erosion, infection, fevers, pain in the low back, stomach, leg, and groin, fatigue, headaches, difficulty with walking and sitting, urinary tract infections, difficulty in voiding, general feeling of unwellness, and painful 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 Key6831753
MDR Text Key84019246
Report Number1835959-2017-00005
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeAS
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 08/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberC-SLH-4S-7X10
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 Received08/29/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 08/30/2017 Patient Sequence Number: 1
Treatment
NONE REPORTED BY THE COMPLAINANT.
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