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

Model Number 288285

Device Problems Material Erosion (1214); Extrusion (2934)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Perforation (2001); Scarring (2061); Complaint, Ill-Defined (2331)

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 ANTERIOR
• 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: 5868595
• MDR Text Key: 51849842
• Report Number: 2125050-2016-00151
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 5013601400
• UDI-Public: 5013601400
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 288285
• Device Catalogue Number: 288285
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/11/2016
• 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