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

Model Number 5196501022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 11/21/2016

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, patient had altis sling for stress incontinence under local anesthesia.On follow up at 6 weeks she was diagnosed with tape exposure in the vagina.She returned to theatre on (b)(6) 2014 and had the tape covered by vagina.She returned on (b)(6) 2016 with recurrence of a small central tape exposure in the vagina.A wait and see plan was agreed.Patient relocated to another area where she had the exposed tape excised in clinic.

• Brand Name: ALTIS 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: 6271058
• MDR Text Key: 65526129
• Report Number: 2125050-2017-00002
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial
• Report Date: 01/23/2017

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: 5196501022
• Device Catalogue Number: 5196501022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 01/23/2017
• 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