MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN URETHRAL SLING

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2007, at (b)(6).The patient and her attorney have alleged that as a result of this/these product(s) 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 catalog number unknown, product unspecified.Mfg date: product manufacture date unknown; lot number unknown.Update: the root cause of the patient¿s current complaints is inconclusive.However, she has obvious lifestyle factors that are likely contributing to her urinary incontinence such as cigarette smoking which contributes to coughing (stress incontinence) and high caffeine consumption (urge incontinence).

Event Description

The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2007, at (b)(6), by dr.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: on (b)(6) 2007, dr.(b)(6) performed a pubovaginal sling procedure with cystoscopy.The patient reported her incontinence was corrected for six months after surgery.The incontinence then returned again unexpectedly with coughing and sneezing.The incontinence has worsened over time.The patient was seen by the surgeon's nurse practitioner and after exams and testing; the patient reported she was told everything was okay.

• Brand Name: BIODESIGN URETHRAL SLING
• Type of Device: 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: 4377141
• MDR Text Key: 5112732
• Report Number: 1835959-2014-00317
• 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: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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
• Date Manufacturer Received: 01/07/2016
• 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
• Patient Weight: 77