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

Model Number 5195622400

Device Problem Material Fragmentation (1261)

Patient Problems Incontinence (1928); Pain (1994); Distress (2329)

Event Date 05/14/2013

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with supris retropubic mesh.Later the patient experienced pain, dyspareunia, incontinence and emotional distress.Excisions of the mesh with a fragments of firm dark pink tissue were performed.

Manufacturer Narrative

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

• Brand Name: SUPRIS RETROPUBIC
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; hummlebaek 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river rd. north; minneapolis MN 55411
• Manufacturer Contact: tim crabtree, manager ; 1601 west river rd. north; minneapolis, MN 55411 ; 6122874164
• MDR Report Key: 3763813
• MDR Text Key: 22268941
• Report Number: 2125050-2014-00249
• 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: 02/24/2014

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: 08/28/2016
• Device Model Number: 5195622400
• Device Catalogue Number: 5195622400
• Device Lot Number: 3239426
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2012
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other