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

Catalog Number J-PF-ANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Bard uretex to trans-obturator urethral support system: (b)(6) 2005.Cook medical biodesign anterior pelvic floor graft: (b)(6) 2012.Neomedic remeex system: (b)(6) 2012.Boston scientific upsylon y-mesh: (b)(6) 2015.Bard uretex to trans-obturator urethral support system: (b)(6) 2005.Cook medical biodesign anterior pelvic floor graft: (b)(6) 2012.Neomedic remeex system: (b)(6) 2012.Boston scientific upsylon y-mesh: (b)(6) 2015.

Event Description

The patient was reportedly implanted with a bard uretex to trans-obturator urethral support system, on (b)(6) 2005, at (b)(6).The patient was also reportedly implanted with two cook medical biodesign anterior pelvic floor grafts and a neomedic remeex system, on (b)(6) 2012, at the medical center of (b)(6).Additionally, the patient was reportedly implanted with a boston scientific upsylon y-mesh, on (b)(6) 2015, at the medical center of (b)(6).The patient and her attorney have alleged that as a result of these products being implanted in the patient, the patient has experienced pain, injury, and has undergone medical treatment.

• 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
• Manufacturer Contact: perry guinn ; 1425 innovation place; west lafayette, IN 47906 ; 7654973355
• MDR Report Key: 5173967
• MDR Text Key: 29183012
• Report Number: 1835959-2015-00226
• Device Sequence Number: 1
• Product Code: FTL
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• 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
• Date Manufacturer Received: 10/09/2015
• 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