MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN URETHRAL SLING; SURGISIS URETHRAL SLIING

Catalog Number UNSPECIFIED

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Patient involvement (2648)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a stratasis urethral sling on (b)(6) 2003, at (b)(6).The pt and her attorney have alleged that as a result of this/these product(s) 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

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 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 follow up mdr will be filed.

• Brand Name: BIODESIGN URETHRAL SLING
• Type of Device: SURGISIS URETHRAL SLIING
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp qa/ra ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4462219
• MDR Text Key: 5399584
• Report Number: 1835959-2015-00028
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 01/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNSPECIFIED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2015
• 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: NONE REPORTED BY THE COMPLAINANT
• Patient Outcome(s): Disability