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

Catalog Number J-PF-4-POST

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a bard pelvicol acellular collagen matrix and an ams monarc subfascial hammock on (b)(6) 2007, at (b)(6).The pt was implanted with a surgisis posterior pelvic floor graft on (b)(6) 2013, at (b)(6).The pt and her attorney have alleged that as a result of these product being implanted in the pt, the pt has experienced pain, injury, and has undergone medical treatment.The following info was not provided by the complainant: specific info of the alleged injury, specific info regarding whether intervention was performed, specific info regarding why intervention was performed or what type / to what extent intervention was performed.Specific correlation between device performance and alleged injury, current pt status.

Manufacturer Narrative

Product expire date unk; lot number not provided.Ec conclusion code: root cause inconclusive due to lack of details provided by the complainant.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 info provided by the complainant, details regarding a specific correlation between the surgisis posterior pelvic floor graft's performance and the alleged injury remain unk.A root cause of the claim allegations is inconclusive due to the lack of details provided by the complainant.All other matters relating to this litigation are being handled by our attorney.If/when add'l info is obtained, a f/u mdr will be filed.

• Brand Name: BIODESIGN POSTERIOR PELVIC FLOOR GRAFT
• Type of Device: POSTERIOR 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 Key: 3893846
• MDR Text Key: 20267908
• Report Number: 1835959-2014-00230
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/12/2014

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 Number: J-PF-4-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/12/2014
• 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 Number: 1
• Treatment: AN AMS MONARC SUBFASCIAL HAMMOCK; BARD PELVICOL ACELLULAR COLLAGEN MATRIX
• Patient Outcome(s): Disability