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

Model Number 5195512400

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Emotional Changes (1831); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Skin Erosion (2075); Urinary Retention (2119); Deformity/ Disfigurement (2360); Prolapse (2475); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient with this device experienced incomplete bladder emptying, pelvic pain, bladder stone, and mesh erosion into bladder.

Manufacturer Narrative

D4 lot number: 1741439.

Event Description

Additional information received further reported that the patient also experienced complications associated with transvaginal mesh including: severe pain with daily activities and intercourse, emotional pain, urinary incontinence, physical deformity, loss of the ability to perform sexually, erosion of the vaginal wall and other tissues, infection, and permanently diminished enjoyment of life.The patient had undergone extensive medical treatment including but not limited to operations to locate and remove mesh, repair pelvic organs, tissue, and nerve damage.Pain control and other medications, including injections, had been administered.

• 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: 12193540
• MDR Text Key: 262424319
• Report Number: 2125050-2021-00930
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 05708932442961
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 04/15/2022
• Supplement Dates FDA Received: 04/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female