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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE
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COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE Back to Search Results
Catalog Number 93-4400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Distress (2329)
Event Type  Injury  
Event Description
According to the available information a summons was received indicating the following: the patient has suffered severe emotional pain and injury and has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries as a result of the implantation of mesh.On (b)(6) 2019 the patient was implanted with aris.On (b)(6) 2021, after suffering from eroded vaginal mesh into her urethra, patient underwent a vaginal removal of aris mesh.
 
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Brand Name
ARIS TRANSOBTURATOR SYSTEM
Type of Device
SUTURE/NEEDLE PASSER, SINGLE-USE
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18527295
MDR Text Key333046308
Report Number2125050-2024-00100
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050148
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number93-4400
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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