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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2002, 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 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 stratasis 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 litigation are being handled by our attorney.If/when additional information is obtained a follow-up mdr will be filed.

Manufacturer Narrative

Product common name is surgical mesh; product code is pag.Update: based on a review of the additional details received, a root cause of the patient¿s recurrent urinary incontinence is inconclusive.Due to the lack of medical follow-up, other contributing factors to the urinary incontinence and/or other potential contributing factors cannot be confirmed or ruled out.As such, the root cause of the reported lack of effectiveness of the biodesign urethral sling is inconclusive.Many factors can contribute to this including, but not limited to, surgical technique, patient postoperative care, and postoperative activity.Lack of effectiveness and recurrence of original defect are known potential complications of most surgical procedures.

Event Description

The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2002, (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 pain, injury, and has undergone medical treatment.Update: the (b)(6) 2002 surgery included placement of a pubovaginal sling with sis graft and a cystoscopy.The patient was released to home the following day.The patient reported that approximately one-week post surgery her incontinence returned.The patient reported occasional urinary tract infections that resolve with antibiotics.The patients also reported dyspareunia.The patient has not sought out further evaluation, diagnosis, or treatment for the urinary incontinence.

• Brand Name: BIODESIGN URETHRAL SLING
• Type of Device: SURGISIS URETHRAL SLING
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 4425670
• MDR Text Key: 5282692
• Report Number: 1835959-2015-00008
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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: UNKNOWN
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• 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
• Patient Outcome(s): Disability