MAUDE Adverse Event Report: COLOPLAST CORP (OUT)ARIS TRANS-OBTURATOR SLIN; SURGICAL MESH

Model Number 5195102400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 01/23/2007

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This mdr is created to document the asr / product code otn / exemption # (b)(4).Total number of events: 77, aris: 66, follow-up 4, supris:6, follow-up 1.

Event Description

As reported to coloplast though not verified, patient's legal representative stated, in a correspondence to coloplast that the patient was implanted with coloplast aris mesh and experienced injuries.

• Brand Name: (OUT)ARIS TRANS-OBTURATOR SLIN
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis, MN 55411
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west rivier road north; minneapolis MN 55411
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 8728188
• MDR Text Key: 148996834
• Report Number: 2125050-2019-00495
• 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: other
• Type of Report: Initial
• Report Date: 06/20/2019

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: Health Professional
• Device Model Number: 5195102400
• Device Catalogue Number: 519510
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 06/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other