MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS AMS INTEXEN-PORCINE DERMIS; MESH, SURGICAL

Model Number 720127-01

Device Problem Insufficient Information (3190)

Patient Problems Urinary Retention (2119); Urinary Frequency (2275); No Code Available (3191)

Event Date 08/23/2013

Event Type  Injury  

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced urinary urgency, urinary frequency, and urinary retention.It was also reported that the plaintiff allegedly experienced recurrent urinary tract infection, stress urinary incontinence, hesitancy, dribbling, suprapubic abdominal and lower back pain, spasms in the urethra, nausea after voiding, foul-smelling urine, incontinence at night and pelvic organ prolapse.The device remains implanted.No further complications have been reported in relation to this event.

Manufacturer Narrative

(b)(4).

• Brand Name: AMS INTEXEN-PORCINE DERMIS
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4338650
• MDR Text Key: 5175562
• Report Number: 2183959-2014-70605
• Device Sequence Number: 1
• Product Code: PAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/24/2014

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: Lay User/Patient
• Device Expiration Date: 07/31/2015
• Device Model Number: 720127-01
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MENTOR OB TAPE
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Weight: 113