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

Catalog Number J-STFK-8-2X40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a boston scientific xenform and a biodesign surgisis tension-free urethral sling on (b)(6) 2013, by (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.

• Brand Name: BIODESIGN TENSION-FREE URETHRAL SLING KIT
• Type of Device: SURGISIS TENSION-FREE URETHRAL SLING KIT
• Manufacturer (Section D): COOK BIOTECH, INC.; west lafayette IN 47906
• Manufacturer Contact: perry guinn, vp qa/ra ; 1425 innovation place; west lafayette, IN 47906-1000 ; 7654973355
• MDR Report Key: 4337983
• MDR Text Key: 5180580
• Report Number: 1835959-2014-00981
• 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: 12/08/2014

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: Health Professional
• Device Expiration Date: 01/31/2015
• Device Catalogue Number: J-STFK-8-2X40
• Device Lot Number: LB653139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 12/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC XENFORM PRODUCT CODE 830-247; LOT NO. 1306065 ON
• Patient Outcome(s): Disability