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

Model Number 5195511400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Deformity/ Disfigurement (2360); No Information (3190); No Code Available (3191); Urinary Incontinence (4572)

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 and intercourse and required revision surgery.Operations to attempt to locate and remove mesh, repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various area of the pelvis, spine and the vagina and operators to remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.

Event Description

Additional information received on 09/12/2021.On (b)(6) 2016: partial excision of aris/mentor, exam under anesthesia, denuding/closure of vaginal mucosa beneath erosion site, cystoscopy.Intraoperative findings: ~1 cm aris/mentor erosion at midurethra.Excision size: 1-1.5 cm.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• Brand Name: ARIS TRANSOBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10098874
• MDR Text Key: 193610409
• Report Number: 2125050-2020-00406
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5195511400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2021
• 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; Required Intervention
• Patient Sex: Female