MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR KIT; SURGICAL MESH

Model Number 5195501000

Device Problems Material Erosion (1214); Material Protrusion/Extrusion (2979)

Patient Problems Micturition Urgency (1871); Incontinence (1928)

Event Date 09/24/2009

Event Type  Injury  

Manufacturer Narrative

This mdr is created as an additional follow-up to mdr record # 2125050-2013-00467, initially reported on 11/04/2013 through esubmitter.This mdr is to reflect the additional information received.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the implanted device lot number not being provided, a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

As reported to coloplast, though not verified, additional information received on 04/08/2021.Dyspareunia with penile trauma, post micturition dribbling, mesh extrusion distal 1/3 vagina/suburethral, vaginal mesh erosion (no operative note included), urge incontinence with nocturia, granulation lesion r midline with tenderness.The device was not available for evaluation.However, because qa¿s examination may not conclusively confirm or disprove the report of erosion, qa accepts the physician¿s observations of such as the reason for surgical intervention.If additional information is received, qa will re-evaluate this complaint in accordance to procedures.Therefore, no additional action is required at this time.

• Brand Name: ARIS TRANSOBTURATOR KIT
• 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: 12305419
• MDR Text Key: 265974531
• Report Number: 2125050-2021-01131
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2021

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: Health Professional
• Device Model Number: 5195501000
• Device Catalogue Number: 519550
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54