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

Model Number 5195512400

Device Problem Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Tissue Damage (2104); Urinary Tract Infection (2120); Discharge (2225); Deformity/ Disfigurement (2360); Prolapse (2475); No Information (3190); No Code Available (3191); Constipation (3274); Dyspareunia (4505)

Event Date 07/10/2018

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, the legal representative stated dyspareunia, severe pelvic pain, urinary urgency problems, incontinence, and difficulty with daily activities.Suffered and will suffer infections, pain, discharge, and multiple corrective surgeries.Operations to locate and remove mesh, attempt to 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 operations to remove portions of the female genitalia.Urinary incontinence, physical deformity and loss of the ability to perform sexually.This patient also had a novasilk mesh product implanted.The novasilk has been reported under 2125050-2020-00432.

Manufacturer Narrative

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, additional information received on 06/26/2021.Pelvic pain near the bladder neck and at the left pelvic sidewall, dyspareunia, urinary urgency and difficulty emptying the bladder; scar tissue and desmoplastic reaction around the mesh with adherence to perirectal tissues.No other adverse patient effects were reported.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

Event Description

Additional information received on (b)(6) 2023 provides the following patient symptoms, cystocele and rectocele, uterovaginal prolapse.Chronic urinary tract infection.

• 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: 10152900
• MDR Text Key: 195096480
• Report Number: 2125050-2020-00433
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• 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,Followup,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 5292565
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2023
• 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; Other
• Patient Age: 53 YR
• Patient Sex: Female