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

Model Number 5014501400

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Hematuria (2558)

Event Date 09/20/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to coloplast, though not verified, the patient's legal representative stated recurrent stress urinary incontinence, hematuria, ua leukocytes 3+. Mesh exposure, bleeding, mild pain, dyspareunia, severe pain at vaginal.

• Brand Name: RESTORELLE DIRECTFIX ANT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 6090445
• Report Number: 2125050-2016-00355
• Device Sequence Number: 1
• Product Code: FTL
• 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,other
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 5014501400
• Device Catalogue Number: 5014501400
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2016
• 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

• Patient Age: 72 YR
• Patient Outcome(s): Other