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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN ANTERIOR PELVIC FLOOR GRAFT

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COOK BIOTECH, INC. BIODESIGN ANTERIOR PELVIC FLOOR GRAFT Back to Search Results
Catalog Number UNSPECIFIED
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348)
Event Type  Injury  
Event Description
The patient was reportedly implanted with a boston scientific obtryx transobturator mid-urethral sling system on (b)(6) 2011, at (b)(6) by dr.(b)(6).The patient was implanted with a surgisis bio anterior of (b)(6) 2013, at (b)(6) by dr.(b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.The following information was not provided by the complainant: specific information of the alleged injury, specific information regarding whether intervention was performed, specific information regarding why intervention was performed or what type/to what extent intervention was performed, specific correlation between device performance and alleged injury, current patient.
 
Manufacturer Narrative
Method code: actual device not evaluated; no testing methods performed; as product not returned to cbi.Results code: no results available since no evaluation performed; as product not returned to cbi.Investigation into this claim included a review of the claim allegations and all other communication and investigation into this report/claim is being handled by our attorney.Based on the information provided by the complainant, details regarding a specific correlation between the biodesign anterior pelvic floor graft's performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when additional information is obtained a follow-up mdr will be filed.
 
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Brand Name
BIODESIGN ANTERIOR PELVIC FLOOR GRAFT
Type of Device
ANTERIOR PELVIC FLOOR GRAFT
Manufacturer (Section D)
COOK BIOTECH, INC.
west lafayette IN 47906
Manufacturer Contact
perry guinn, vp
1425 innovation place
west lafayette, IN 47906
7654973355
MDR Report Key4012359
MDR Text Key4692056
Report Number1835959-2014-00275
Device Sequence Number1
Product Code PAI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNSPECIFIED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/11/2014
Initial Date FDA Received07/31/2014
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
URETHRAL SLING SYSTEM; BOSTON SCIENTIFIC OBTRYX TRANSOBTURATOR MID-
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