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

Catalog Number J-STFK-8-2X40

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemorrhage/Bleeding (1888); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Injury (2348)

Event Type  Injury  

Event Description

The pt was reportedly implanted with pelvic mesh products during surgery performed to treat her pelvic organ prolapse and/or stress urinary incontinence.The pt and her authority have alleged that as a result of having the products implanted in her, the pt has experienced pain, injury, and has undergone corrective surgery.On (b)(6) 2009, the pt underwent implantation of a surgisis biodesign tension-free urethral sling, by dr (b)(6), for the treatment of her mixed urinary incontinence.On (b)(6) 2012, the pt had complaints of stress urinary incontinence and urge urinary incontinence; she was diagnosed with overactive bladder.On (b)(6) 2012, had complaints of vaginal bleeding.On (b)(6) 2012, the pt underwent urodynamic testing which showed no evidence of stress urinary incontinence.The pt was started on a 3 week trail of enablex.The following information was not provided by the complainant: specific information of the alleged injury.Specific info regarding whether intervention was performed.Specific info regarding why intervention was performed or what type / to what extend intervention was performed.Specific correlation between device performance and alleged injury.Current pt status.

Manufacturer Narrative

Ec results code - root cause inconclusive.Investigation into this claim has included a review of the cbi complaint system, and all other communication and investigation into this report/claim was handled by our attorney.Update - additional investigation into this claim included another review of the cbi complaint system, a review of the device history records which indicated that product was manufactured to specifications, and a review of the surgisis biodesign tension-free urethral sling ifu fp0015-3b.The claim did not provide enough evidence to suggest that a cbi manufactured product was implanted in the pt or was the direct cause of the alleged injuries to the pt.Cook biotech incorporated (and any other cook companies that may have been listed ) was dismissed without prejudice as a defendant from the associated claim.As such, this complaint will be closed without further investigation from cook biotech incorporated.Update- after reviewing the additional details received, it does not appear that the surgisis biodesign tension-free ureteral sling caused or contributed to any life threatening illness or injury, permanent impairment or damage, nor did the pt require medical or surgical intervention to preclude serious injury or death as a result of sling being placed.The pt did not experienced any symptoms as a result of the surgisis biodesign tension-free urethral sling being placed that should they recure would be likely to cause or contribute to death, serious injury, or require medical or surgical intervention to prelude serious injury or death.Based on the information provided by the complainant, details regarding a specific correction between the surgisis biodesign tension-free urethral sling's performance and the alleged injury remain unk.A root cause of the claim allegations is inconclusive.All other matters 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 fuinn, vp ; 1425 innovation place; west lafayette, IN 47906-1000 ; 7654973355
• MDR Report Key: 3692670
• MDR Text Key: 4254963
• Report Number: 1835959-2014-00018
• 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: Attorney
• Type of Report: Initial
• Report Date: 03/11/2014

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: 06/30/2010
• Device Catalogue Number: J-STFK-8-2X40
• Device Lot Number: LB392206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2008
• 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