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

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Hematuria (2558); Blood Loss (2597); Dysuria (2684)

Event Date 04/22/2014

Event Type  Injury  

Manufacturer Narrative

Exemption-(b)(4).Total number of events summarized - (b)(4).Ams intexen-porcine dermis.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced erosion, dyspareunia, vaginal bleeding, microscopic hematuria, urgency, exposure, stress incontinence, fecal incontinence, urinary tract infection/bladder infection, dysuria, and bladder/groin pain.The plaintiff underwent mesh excision.The mesh was partially explanted.No further patient complications have been reported in relation to this event.

• Brand Name: AMS INTEXEN-PORCINE DERMIS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 5146723
• MDR Text Key: 28136632
• Report Number: 2183959-2015-58008
• 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: consumer,other
• Reporter Occupation: Attorney
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• 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
• Treatment: MONARC
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR
• Patient Weight: 84