MAUDE Adverse Event Report: COLOPLAST A/S SUPRIS SUPRAPUBIC; SURGICAL MESH

Model Number 5195611400

Device Problems Leak/Splash (1354); Extrusion (2934)

Patient Problems Erosion (1750); Pain (1994); Urinary Frequency (2275)

Event Date 05/02/2012

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with supris suprapubic mesh.Later the patient experienced mesh erosion and extrusion, urinary leakage, urinary frequency, joint pain and back pain.A removal and excisions of mesh with cytoscopy were performed.

Manufacturer Narrative

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

• Brand Name: SUPRIS SUPRAPUBIC
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlenaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST CORP; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: tim crabtree, manager ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874164
• MDR Report Key: 3763687
• MDR Text Key: 4483551
• Report Number: 2125050-2014-00056
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K111233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 01/15/2014

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: 12/31/2014
• Device Model Number: 5195611400
• Device Catalogue Number: 5195611400
• Device Lot Number: 2633937
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2010
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other