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

Model Number 5010002400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Micturition Urgency (1871); Itching Sensation (1943); Urinary Tract Infection (2120); Burning Sensation (2146); Fungal Infection (2419); Dysuria (2684); Dyspareunia (4505); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Lot number: 2406755.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This event was previously submitted via asr on 24jun2019 (exemption number e2014015); this report is intended to be a follow up report to submit additional information that has been received.

Event Description

Additional information received further reported that in (b)(6) 2013, the patient had experienced recurrent urinary tract infections, malodorous urine, dysuria, candida vaginitis, vaginal atrophy, recurrent incontinence, dyspareunia, urgency, vaginal dryness with burning and itching, chronic pelvic pain, and overactive bladder.In (b)(6) 2018 the patient underwent excision of midurethral sling, lysis of vaginal adhesions, removal of anterior prolapse mesh, cystourethroscopy, and vulvar biopsy under general anesthesia.

• Brand Name: EXAIR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12562665
• MDR Text Key: 274282302
• Report Number: 2125050-2021-01415
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR