MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN TENSION FREE URETHRAL SLING; SURGISIS TENSION FREE URETHRAL SLING

Catalog Number STFK-8-2X40

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with an unspecified stratasis mesh on (b)(6) 2004 at (b)(6).The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient has experienced loss, injury, and damage.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 performances and alleged injury, current patient status.

Manufacturer Narrative

Method - actual device not evaluated.No testing methods performed as product not returned to cbi.Results - no results available since no evaluation performed as product not returned to cbi.Conclusions - root cause inconclusive due to lack of details provided by the complainant.Investigation - evaluation: investigation into this feedback included review of the feedback details received, a review of the cbi complaint system did not reveal any previously filed complaints that match the details provided by the complainant, and all other communication and investigation into this feedback is being handled by our attorney.Summary of investigation findings: based on the information provided by the complainant, details regarding a specific correlation between the biodesign tension-free urethral sling'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 feedback are being handled by our attorney.If/when additional information is obtained a follow-up mdr will be filed.

• Brand Name: BIODESIGN TENSION FREE URETHRAL SLING
• Type of Device: SURGISIS TENSION FREE URETHRAL SLING
• Manufacturer (Section D): COOK BIOTECH; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 3738881
• MDR Text Key: 19967483
• Report Number: 1835959-2014-00020
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020654
• 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: 03/26/2014

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: Other
• Device Catalogue Number: STFK-8-2X40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 03/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED BY THE COMPLAINANT.
• Patient Outcome(s): Disability