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

Catalog Number J-PF-POST

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with an ethicon vicryl mesh and a biodesign or surgisis posterior pelvic floor graft on (b)(6) 2009, at (b)(6) hospital in (b)(6), by dr.(b)(6).The pt and her attorney have alleged that as a result of these products 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 performed and alleged injury; current pt status.

Manufacturer Narrative

Product expiry date unk, lot number not provided.Product manufacture date unk, lot number unk.Investigation to 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.Summary of investigation findings: based on the info provided by the complainant, details regarding a specific correlation between the biodesign or surgisis posterior pelvic floor graft's performance and the alleged injury remain unk.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 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
• 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: 4920941
• MDR Text Key: 6433835
• Report Number: 1835959-2015-00132
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 07/14/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: J-PF-POST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/15/2015
• 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 Number: 1
• Treatment: ETHICON VICRYL MESH
• Patient Outcome(s): Disability