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

Model Number 5195512400

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Hernia (2240); Numbness (2415); Weight Changes (2607); Paresthesia (4421); Dyspareunia (4505); Urinary Incontinence (4572); Swelling/ Edema (4577)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

Lot number: 5348791.This event was previously reported via asr on 26feb2019.This report is intended to be a follow up report to submit additional information that has been received.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 patient experienced severe pain and tight pulling sensations with daily activities and intercourse, and three surgical revisions on (b)(6) 2017, (b)(6) 2017, and (b)(6) 2018.Additional information received further reported that in (b)(6) 2017 the patient had experienced 1 to 1.5 cm of exposed mesh in the right periurethral sulcus.In (b)(6) 2017, 1 millimeter of mesh was exposed in the midurethra.The patient experienced recurrent stress urinary incontinence, and left buttock and groin pain.

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 02/15/2023 indicates that between (b)(6) 2017 through (b)(6) 2020 the patient has experienced the following: swelling of hands, weight gain, paresthesia and numbness, dyspareunia, right inguinal hernia and spotty discharge.On (b)(6) 2019 the patient had a vaginal hysterectomy performed.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12169146
• MDR Text Key: 261646099
• Report Number: 2125050-2021-00912
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

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: Lay User/Patient
• Device Model Number: 5195512400
• Device Catalogue Number: 519550
• Device Lot Number: 5348791
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/20/2023
• Date Device Manufactured: 09/13/2016
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female