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

Model Number 5010002400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 severe pain with daily activities, dyspareunia, recurrence of the pelvic organ prolapse.Stated vaginal prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually.(b)(6) was also implanted on (b)(6) 2013 with the exair and restorelle y contour was implanted on (b)(6) 2016 after a portion of the exair was excised and removed for exposure.

• Brand Name: EXAIR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1-3; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10227876
• MDR Text Key: 197790443
• Report Number: 2125050-2020-00512
• 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: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5010002400
• Device Catalogue Number: 501000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• 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): Hospitalization; Other; Required Intervention