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

Model Number 5195512400

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

Patient Problems Autoimmune Disorder (1732); Hair Loss (1877); Hemorrhage/Bleeding (1888); Neuropathy (1983); Pain (1994); Septic Shock (2068); Urinary Tract Infection (2120); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/22/2010

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 information, bladder sling caused vaginal pain, bleeding, painful intercourse and chronic uti's.Penile laceration to husband during intercourse, neuropathy and sciatica in left leg, difficulty standing, sitting and walking.Four days spent in icu due to septic shock from uti.Development of several autoimmune diseases and over half of pt's hair has been lost since sling was implanted in 2010.

• Brand Name: ARIS TRANS-OBTURATOR KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5858313
• MDR Text Key: 51691791
• Report Number: 2125050-2016-00142
• 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,other
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 5195512400
• Device Catalogue Number: 5195512400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other