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

Catalog Number UNSPECIFIED

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with a stratasis urethral sling on (b)(6) 2007 by dr (b)(6).The pt and her atty have alleged that as a result of this 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 expiry date: unk as lot number not provided.Product manufacture date: unk as lot number unk.Method - actual device not evaluated, no testing methods performed as product not returned to cbi; results - no results available since no eval performed as product not returned to cbi; conclusions - 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 atty.Based on the info provided by the complainant, details regarding a specific correlation between the stratasis urethral sling'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 atty.If/when add'l info is obtained, a f/u mdr will be filed.

• Brand Name: BIODESIGN URETHRAL SLING
• Type of Device: SURGISIS URETHRAL SLING
• 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: 4364130
• MDR Text Key: 5113488
• Report Number: 1835959-2014-00997
• 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: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNSPECIFIED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• 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
• Patient Outcome(s): Disability