MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; SURGICAL MESH

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Discomfort (2330); Deformity/ Disfigurement (2360); Prolapse (2475); Dysuria (2684); No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.(b)(4).Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast though not verified, patient's legal representative stated severe pain with daily activities, persistent urinary tract infections, dysuria, discomfort when voiding.Also stated vaginal prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually.Portion of mesh excised and removed.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• 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 river road north; minneapolis, mn
• Manufacturer Contact: sarah o'gara ; 1601 west river road north; minneapolis, mn
• MDR Report Key: 10228012
• MDR Text Key: 197558527
• Report Number: 2125050-2020-00511
• 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: other
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 3560145
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention