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 Fatigue (1849); Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Numbness (2415); Abdominal Distention (2601); Dysuria (2684); Constipation (3274); Kidney Infection (4502); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)

Event Type  Injury  

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.

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced constipation, abdominal distension, no urge to void and unable to feel when urinating, urinary retention, progressive urinary retention, pain, urinary urgency, nocturia, urinary difficulty, urinary frequency, unable to feel urge to defecate in lower abdomen, urinary tract infections, urinary dyssynergia, chronic fatigue, pelvic floor dysfunction, and dysuria.Patient had revision of the device with transection and cystoscopy under general anesthesia.

• 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: 16095255
• MDR Text Key: 306617467
• Report Number: 2125050-2022-01459
• 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
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 4876248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2022
• Date Device Manufactured: 02/05/2016
• 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
• Patient Age: 56 YR