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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH INCORPORATED BIODESIGN 8-LAYER TISSUE GRAFT; PELVIC FLOOR GRAFT
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COOK BIOTECH INCORPORATED BIODESIGN 8-LAYER TISSUE GRAFT; PELVIC FLOOR GRAFT Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Event Description
The patient was reportedly implanted with a symphasis pelvic floor repair graft on (b)(6) 2006, at (b)(6) hospital in (b)(6), by dr.(b)(6).The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.
 
Manufacturer Narrative
Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.Product manufacture date unknown; lot number unknown.(b)(4).
 
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Brand Name
BIODESIGN 8-LAYER TISSUE GRAFT
Type of Device
PELVIC FLOOR GRAFT
Manufacturer (Section D)
COOK BIOTECH INCORPORATED
1425 innovation place
west lafayette IN 47906
Manufacturer Contact
perry guinn
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key4975776
MDR Text Key6075298
Report Number1835959-2015-00151
Device Sequence Number1
Product Code PAG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 07/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/10/2015
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 Number1
Treatment
NONE REPORTED BY THE COMPLAINANT.
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