MAUDE Adverse Event Report: COOK BIOTECH BIODESIGN ANTERIOR PELVIC FLOOR GRAFT; PELVIC FLOOR ANTERIOR

Catalog Number J-PF-ANT

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Event Description

The patient was reportedly implanted with a biodesign or surgisis anterior pelvis floor graft on (b)(6) 2012, at (b)(6), by (b)(6).The patient and her attorney have alleged that as a result of this product being implanted in the patient, the patient thas 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

Evaluation codes: conclusion code - 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 biodesign or surgisis anterior pelvic floor graft's performance and the alleged injury remain unknown.A root cause of the claim allegations is inconclusive due to a 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

The surgisis anterior pelvic floor graft appears to have performed as intended.The root cause of the patient's current complaints of urinary incontinence, diarrhea, and dyspareunia appear to be unrelated to the implantation of the graft as these symptoms were present prior to the (b)(6) 2012 surgery.The symptoms are likely related to other underlying patient conditions.

Event Description

The patient was reportedly implanted with a biodesign or surgisis anterior pelvic floor graft on (b)(6) 2012, (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) 2012, dr.(b)(6) performed an anterior colporrhaphy with implantation of a surgisis anterior pelvic floor graft for repair of a large anterior cystocele.Prior to the surgery, the patient was experiencing some urinary incontinence and diarrhea.The patient reported that she had no complications during the surgery or her recovery.She reported experiencing stress urinary incontinence at some point after the surgery and she had continued dyspareunia and diarrhea.In an unrelated medical follow-up, on (b)(6) 2015, the practitionernotes indicated that the patient denied abdominal pain, diarrhea, difficulty with voiding, and concern about incontinence and sexual function issues.The patient has not sought out medical evaluation for the urinary incontinence, diarrhea, or dyspareunia.The cystocele repair was successful in that the patient has not had a recurrence of the prolapse.

• Brand Name: BIODESIGN ANTERIOR PELVIC FLOOR GRAFT
• Type of Device: PELVIC FLOOR ANTERIOR
• Manufacturer (Section D): COOK BIOTECH; 1425 innovation place; west lafayette IN 47906 1000
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906-1000 ; 7654973355
• MDR Report Key: 4012384
• MDR Text Key: 4705793
• Report Number: 1835959-2014-00269
• Device Sequence Number: 1
• Product Code: PAI
• 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: 12/15/2015

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: J-PF-ANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• 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
• Patient Weight: 82