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

Model Number 5195512400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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 cellulitis of the vaginal dome and fevers post implant.She was treated with antibiotics.Since this device was implanted, the patient has been treated for 4 urinary tract infections that were positive for e.Coli.Additionally, the patient has experienced frequency of urination, burning sensation, pain at the implant location, difficulty sleeping, abdominal pain, and dysparenia.A ct scan was performed due to recurring symptoms, which did not show erosion.Pain and uti symptoms continued, so effectiveness of the implanted sling was questioned.Subsequently, the patient experienced chronic urethral and pelvic pain, experienced limited movement due to chronic pain, the inability to work, pain radiating from rt iliac down to knee.It was reported that an endoscopic evaluation of the device was planned, but no results have been reported.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

• 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: 12338814
• MDR Text Key: 267235156
• Report Number: 2125050-2021-01163
• 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
• Type of Report: Initial
• Report Date: 08/17/2021

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: Health Professional
• Device Model Number: 5195512400
• Device Catalogue Number: 519551
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/18/2021
• 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: 58 YR