MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN URETHRAL SLING

Catalog Number J-USLH-4S-2X10

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) 2003, at (b)(6) medical center in (b)(6), by dr.(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

(b)(4).Product manufacture date unk, lot number unk.Conclusions: root cause inconclusive due to lack of details provided by the complainant.Investigation - evaluation; 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.Summary of investigation findings: 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 unk.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

Date of event not provided by the complainant.Lot number not provided by the complainant.Product expire date unknown; lot number not provided.Product catalog number unknown, product unspecified.Product manufacture date unknown; lot number unknown.Update: the root cause of the patient's current complaints is inconclusive.The patient had three implants, from another manufacturer, implanted subsequent to the stratasis urethral sling, which could be contributing factors to the patient's current complaints.

Event Description

The patient was reportedly implanted with a stratasis urethral sling on (b)(6) 2003, 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.Update: on (b)(6) 2003, dr.(b)(6) implanted a stratasis urethral sling uslh-4s-2x10, in the patient.On (b)(6) 2005, dr.(b)(6) implanted an ams monarch sling in the midurethra, an ams perigee to reduce a cystocele, and an ams apogee posteriorly to reduce a rectocele.

• 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: 4790527
• MDR Text Key: 5802123
• Report Number: 1835959-2015-00084
• 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: 02/03/2016

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-USLH-4S-2X10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• 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