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

Model Number 5014602400

Device Problem Insufficient Information (3190)

Patient Problems Urinary Tract Infection (2120); Complaint, Ill-Defined (2331)

Event Date 07/23/2013

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with a coloplast restorelle directfix posterior mesh.Later the patient experienced recurrent urinary tract infections and mucosal thickening noted in the healed suture line area; macrobid antibiotics and macrodantin were prescribed.

Manufacturer Narrative

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

• Brand Name: RESTORELLE DIRECT FIX POSTERIOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: angela killian - head of ra ; 1601 west river road north; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4406448
• MDR Text Key: 5433252
• Report Number: 2125050-2015-00003
• Device Sequence Number: 1
• Product Code: OTP
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/11/2014

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: Other
• Device Expiration Date: 10/31/2014
• Device Model Number: 5014602400
• Device Lot Number: 2967400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 01/11/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR