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

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Inflammation (1932); Pain (1994); Discomfort (2330); Blood Loss (2597); No Information (3190)

Event Date 04/29/2015

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This mdr has been created to document the asr / product code otp / exemption # e2014015.Total number of events: 3 exair: 3.

Event Description

Legal representative stated plaintiff was implanted with a t-sling and exair and experienced vaginal bleeding and pelvic pain.After a bladder biopsy diagnosed with chronic inflammation.Revision surgery occurred.The plaintiff continues to suffer from vaginal bleeding, sharp pains, blood in urine, dyspareunia, pelvic pain and recurrence of urinary problems.

Manufacturer Narrative

This follow-up mdr is created to document the additional patient information and updated device information.This mdr is created as a follow-up to record 501132 (2125050-2019-00497), initially also reported on product code otp asr exemption # e2014015 for (b)(6) 2019.This mdr is to reflect the additional information to be added to the intial asr report.

Manufacturer Narrative

This follow-up mdr is created to document the additional event information.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information, as reported to coloplast though not verified, indicated urge incontinence and discomfort were also reported by the patient.The sling was completely removed on (b)(6) 2015.

• Brand Name: EXAIR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, MN 3050 ; DA 3050
• MDR Report Key: 8728189
• MDR Text Key: 149060399
• Report Number: 2125050-2019-00497
• 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,Followup,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• 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: 4177772247
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR