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

Model Number 5013801400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Internal Organ Perforation (1987); Pain (1994); Scarring (2061); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 06/01/2010

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, patient's legal representative stated pain, erosion, extrusion, exposure, urinary and bowel problems, organ perforation, fistulae, infection, bleeding, dyspareunia, neuromuscular problems, vaginal scarring, excision, severe lower back pain; can not have kids now, removed uterus.

• Brand Name: RESTORELLE DIRECTFIX POSTERIOR
• 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: 5866869
• MDR Text Key: 51815306
• Report Number: 2125050-2016-00150
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5013801400
• Device Catalogue Number: 5013801400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR