MAUDE Adverse Event Report: COLOPLAST CORP EXAIR ANTERIOR; SURGICAL MESH

Catalog Number 5010001400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 07/06/2012

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Response made because device was not returned.(b)(4).

Event Description

As reported to coloplast though not verified, patient was implanted with exair anterior mesh.Later the patient experienced incontinence, pain, dyspareunia and dryness.The patient was implanted with a competitor's product and a revision of the existing mesh were performed.

• Brand Name: EXAIR ANTERIOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west river road north; minneapolis MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: janell colley ; 1601 west river road north; minneapolis, MN 55411 ; 6122874237
• MDR Report Key: 5047944
• MDR Text Key: 24768877
• Report Number: 2125050-2015-00088
• 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: consumer
• Report Date: 06/16/2015

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 Catalogue Number: 5010001400
• Device Lot Number: 2382591
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR