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

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Injury (2348); Prolapse (2475); No Information (3190)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa review.No trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated plaintiff suffered severe pain with daily activities and intercourse, bowel problems, and rectal bleeding.Plaintiff underwent a surgical procedure during which her physicians excised and removed a portion of the mesh due to mesh erosion.Plaintiff has suffered, and continues to suffer, multiple, severe and painful personal injuries, including, but not limited to, vaginal prolapse, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.

Event Description

Additional information received reported the patient experienced urinary tract infections between (b)(6) 2016 and (b)(6) 2017, treated with rocephin on (b)(6) 2016.Revision surgery on (b)(6) 2018 documented no erosion of the mesh into the vagina, but did have a small area of erosion in the left anterior distal rectum.

• Brand Name: EXAIR ANTERIOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 9490786
• MDR Text Key: 172092781
• Report Number: 2125050-2019-01146
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

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: Lay User/Patient
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Device Lot Number: 4462655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 08/19/2022
• 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
• Patient Sex: Female