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

Catalog Number J-STF-8-2X40

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a ethicon tvt-o on (b)(6) 2008, at (b)(6), by dr (b)(6).The patient was implanted with a biodesign surgisis tension-free urethral sling on (b)(6) 2013, at (b)(6), by dr (b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.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 performance and alleged injury; current patient status.

Manufacturer Narrative

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 attorney.Based on the information provided by the complainant, details regarding a specific correlation between the biodesign surgisis 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 maters relating to this litigation 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, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4425672
• MDR Text Key: 16172158
• Report Number: 1835959-2015-00006
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020654
• 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: 01/13/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: J-STF-8-2X40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/14/2015
• 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 TVT-O
• Patient Outcome(s): Disability