MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANS-OBTURATOR; SURGERICAL MESH

Model Number UR31011002

Device Problem Extrusion (2934)

Patient Problem No Information (3190)

Event Date 06/20/2010

Event Type  Injury  

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available in formation, vaginal extrusion of tot.Tape papalble in vagina.

Manufacturer Narrative

This follow-up mdr is created to document/correct the address (manufacturing site address).

• Brand Name: ARIS TRANS-OBTURATOR
• Type of Device: SURGERICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): ABISS (ANALYTIC BIOSURGICAL SOLUTIONS); 14 rue de la télématiquefran; saint etienne, f-42000 MN ; FR
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 7201733
• MDR Text Key: 97632546
• Report Number: 2125050-2018-00037
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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: Physician
• Device Model Number: UR31011002
• Device Catalogue Number: UR31011002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2018
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/06/2018
• Supplement Dates FDA Received: 02/01/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other