MAUDE Adverse Event Report: COLOPLAST A/S (MPO)EXAIR ANTERIOR KIT; SURGICAL MESH

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This mdr is created to document the asr / product code otp / exemption # (b)(4).Total number of events: 1.Exair: 1.

Event Description

As reported to coloplast though not verified, patient's legal representative stated vaginal mesh erosion.

• Brand Name: (MPO)EXAIR ANTERIOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west rivier road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 8371380
• MDR Text Key: 137183044
• Report Number: 2125050-2019-00164
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K112386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Device Lot Number: 4085013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other