MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX POS; SURGICAL MESH

Model Number 5014601400

Device Problem Extrusion (2934)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Cramp(s) (2193); Discharge (2225); Discomfort (2330); Injury (2348); Dysuria (2684); Foreign Body In Patient (2687)

Event Date 01/09/2012

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with restorelle directfix pos mesh.Later the patient experienced vaginal and pelvic pain, discharge, dysuria, urgency, frequency, mixed incontinence, nocturia, splinting with bowel movement, mesh exposure and extrusion, stress urinary incontinence, bladder spasms, foul smelling urine, change in urine color, cramping, vaginal foreign body, discomfort, urinary tract infections, dyspareunia, urinary retention, hesitancy, rectal incontinence and patient alleges spouse can feel and was cut by material during intercourse.Anticholinergics, antibiotics, analgesics, estrogen, pyridium and antifungals were prescribed.An excision of the mesh with rectal sphincteroplasty was performed.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: RESTORELLE DIRECTFIX POS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian, head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 3984591
• MDR Text Key: 4632127
• Report Number: 2125050-2014-00386
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 5014601400
• Device Catalogue Number: 5014601400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other