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

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

Patient Problems Hematoma (1884); Incontinence (1928); Hernia (2240); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

This report was created to document the additional information received for asr e2014015 period june-july 2017 otn.

Event Description

As reported to coloplast though not verified, patient's legal representative stated grade iii cystocele which caused patient to have lower leg pain, bleeding, and recurrence of her original problems causing debilitating pain.Initial reported on asr e2014015 period june-july 2017 otn.

• Brand Name: ARIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• 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: 9153356
• MDR Text Key: 162472089
• Report Number: 2125050-2019-00838
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1