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

Model Number 5196502400

Device Problem Migration (4003)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Dysuria (2684); Dyspareunia (4505); 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 recurrent urinary tract infections about every 2 months, chronic pelvic pain, urethral stricture or narrowing, device exposure, bladder pain, urgency, frequency, dyspareunia, pelvic and perineal pain, dysuria, difficulty urinating, vaginal pain, stress urinary incontinence, chronic urethral / device pain, and scar tissue.The patient had the device explanted, cystourethroscopy, a pfannenstiel counter incision and suprapubic exploration under general endotracheal anesthesia.Pathology results included a foreign-body giant cell reaction, three tan-pink, irregular mucosal soft tissue fragments ranging from 0.4 x 0.3 x 0.1cm to 3.5 x 1.0 x 0.3 cm.A single blue suture extending from the largest fragments 3.5 cm in length was also noted.

• 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: 15681997
• MDR Text Key: 302505285
• Report Number: 2125050-2022-01161
• 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: 10/27/2022

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: 08/26/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5148264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 10/27/2022
• Date Device Manufactured: 08/26/2016
• 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: 51 YR