MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR KIT; SURGICAL MESH

Model Number 5195512400

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Discharge (2225); Injury (2348); Deformity/ Disfigurement (2360); Dysuria (2684); No Information (3190); No Code Available (3191); Sexual Dysfunction (4510)

Event Date 04/09/2018

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, patient's legal representative stated severe pelvic pain, urinary problems, incontinence, infections, difficulty with daily activities.Many women, including patient, undergo 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 areas of the pelvis, spine and the vagina, and remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.Has suffered and will suffer infections, pain, discharge and multiple corrective surgeries.

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, legal representative stated severe pelvic pain, urinary problems, incontinence, infections, difficulty with daily activities.Many women, including patient, undergo 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 areas of the pelvis, spine and the vagina, and remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.Has suffered and will suffer infections, pain, discharge and multiple corrective surgeries.

Event Description

Additional information received on 02/12/2023 indicates the following: beginning (b)(6) 2014 through (b)(6) 2018 the patient has experienced dysuria and has been treated for urinary tract infections with medications.

Manufacturer Narrative

Correction to medical device problem code, clinical sign & symptoms codes, and investigation codes.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.

• Brand Name: ARIS TRANS-OBTURATOR 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: 10169526
• MDR Text Key: 195613312
• Report Number: 2125050-2020-00463
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2018
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Device Lot Number: 3782956
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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: 65 YR
• Patient Sex: Female