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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Tissue Damage (2104); Discharge (2225); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Nervous System Injury (2689); No Information (3190); No Code Available (3191); Genital Bleeding (4507)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.(b)(4).

Event Description

According to the available information, the legal representative stated severe pelvic pain, urinary and voiding problems, incontinence, difficulty with daily activities and subsequent surgeries, severe emotional pain and injury and has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries, removal of mesh, operations to attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine and the vagina and operations to remove portions of the female genitalia, physical deformity, the loss of the ability to perform sexually, and erosion.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported that in (b)(6) 2017, prior to implant, the patient had been experiencing recurrent stress urinary incontinence (sui) and recurrent hypomobile urethra and bladder neck.The altis was implanted with prolete tension suture, and cystoscopy took place.Intraoperative findings at that time included severe sui.The altis was readjusted/tensioned intraoperatively, and a prolene tension suture was placed around the altis for anticipated further postoperative adjustment.In (b)(6)2017, the patient experienced anterior wall altis extrusion, and vaginal bleeding/discomfort.Partial excision of the altis took place on (b)(6) 2017, as well as tightening and removal of the prolene tension suture.Cystoscopy took place.Intraoperative findings: midline altis extrusion/exposure at 6:00 below mid urethra, and exposure of prolene tension suture.

• 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: brian schmidt ; 1601 west river road; minneapolis, MN 55411 ; 6128651177
• MDR Report Key: 10288169
• MDR Text Key: 199234514
• Report Number: 2125050-2020-00528
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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: 5124765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• 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; Required Intervention; Other
• Patient Sex: Female