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

Model Number 5196502400

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

Patient Problems Emotional Changes (1831); Pain (1994); Urinary Frequency (2275); Deformity/ Disfigurement (2360); Hematuria (2558); Kidney Infection (4502); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced dyspareunia, severe pelvic and vaginal pain, urinary problems, urinary incontinence, difficulty with daily activities, loss of ability to perform sexually, physical deformity, emotional pain and had a cystoscopy.Patient had device explanted.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.There were no nonconforming reports nor capas identified as associated with this lot #.

Event Description

Additional information received on 1/10/2023 provides the following: between (b)(6) 2014 and (b)(6) 2021 the patient experienced urinary tract infections with hematuria and urinary frequency.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16096356
• MDR Text Key: 306633387
• Report Number: 2125050-2022-01460
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2017
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4060195
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/10/2023
• Supplement Dates FDA Received: 01/16/2023
• Date Device Manufactured: 06/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention