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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Pocket Erosion (2013); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint, the device not being returned for evaluation and the implanted device lot number not being provided, a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

Event Description

Vaginal discharge, dysuria, uti, sui, vaginitis, difficulty voiding, hematuria, urethral discharge, erosion, urgency, bladder pains, recurrent utis, urinary frequency, nocturia, exposed/eroded vaginal discharge, sui, exposure, mid urinary incontinence, sling excision.As reported to coloplast, though not verified, additional information received on 03/31/2021.Fungal vaginitis and recurrent leakage.On (b)(6) 2017, placement of advantage/fit sling for recurrent sui.Scarring on vaginal mucosa at the level of the midurethra from prior sling removal (altis) is noted.Failed voiding trial and discharged to home with foley catheter.On (b)(6) 2021, c/o of urinary leakage, vaginal pain, dyspareunia, vaginal discharge with odor, dysuria, post void urinary leakage.Trigger point pain in bilateral puborectalis muscles at insertion of tot (altis) sling anchors.No other adverse patient effects were reported.

• 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12658504
• MDR Text Key: 279336999
• Report Number: 2125050-2021-01512
• 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: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 4060195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57