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

Model Number 5195501000

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Hematuria (2558); Intermenstrual Bleeding (2665); Kidney Infection (4502)

Event Date 03/17/2021

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced erosion of the device in the midline approximately 3 cm from urethral meatus leading to removal of eroded vaginal mesh, and partial removal of suburethral sling under general anesthesia.

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

Event Description

Additional information received 11/12/2022 as follows: beginning (b)(6) 2018 through (b)(6)2021 the patient experienced hematuria with uti, mild cystocele.Vaginal bleeding with vaginal pain.Urinary incontinence when waiting too long to void.

Manufacturer Narrative

Correction: item number.

• 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: 14016057
• MDR Text Key: 288620429
• Report Number: 2125050-2022-00358
• 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: 11/29/2022

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: 5195501000
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 11/12/2022
• Supplement Dates FDA Received: 11/29/2022
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female