MAUDE Adverse Event Report: COLOPLAST A/S EXAIR; OTP

Model Number 5010001400

Device Problem Insufficient Information (3190)

Patient Problems Granuloma (1876); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Fungal Infection (2419)

Event Date 08/26/2013

Event Type  Injury  

Event Description

As reported to coloplast though not verified, patient was implanted with exair mesh.Later the patient experienced urinary tract infections, dyspareunia, granulation tissue, elevated residual urine and probable hypersuspension of urethrovesical (uv) junction, urinary frequency, incomplete bladder emptying, vaginal pain, yeast infection and pain with heavy lifting.The patient underwent an excision of the granulated tissue, wound closure, cystoscopy and bilateral retrograde pyelogram.No explant procedure was reported.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).Device not returned.

• Brand Name: EXAIR
• Type of Device: OTP
• Manufacturer (Section D): COLOPLAST A/S; holtedam-1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 w. river road n.; minneapolis MN 55411
• Manufacturer Contact: angela kilian-head of ra ; 1601 w. river road n.; minneapolis, MN 55411 ; 6122874236
• MDR Report Key: 4039851
• MDR Text Key: 4801074
• Report Number: 2125050-2014-00396
• 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: Attorney
• Type of Report: Initial
• Report Date: 08/27/2014

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: Other
• Device Model Number: 5010001400
• Device Catalogue Number: 5010001400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other