MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH, PRODUCT CODE: PAH

Model Number 5196501022

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

Patient Problems Micturition Urgency (1871); Hematoma (1884); Pain (1994); Urinary Retention (2119); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

An abstract stated two patients presented vaginal extrusion and two patients suffered limited vaginal hematoma (no iuga).Three patients developed de novo urgency urinary incontinence.One patient presented self-limited urinary retention and needed self-catheterization.High post voiding residue was assessed in two patients.Urodynamics were performed and bladder outlet obstruction was probed, with the result that sling was cut.Chronic groin pain was developed in two patients, and they have been treated with pharmacological and physical treatments.

Manufacturer Narrative

This initial report is being submitted per fda request.This report was previously submitted as a supplemental report in error on september 18, 2018.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH, PRODUCT CODE: PAH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek 3050, dk
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6124345685
• MDR Report Key: 7885799
• MDR Text Key: 313590470
• Report Number: 2125050-2018-00706
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

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: Health Professional
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female