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

Model Number 5196502400

Device Problem Insufficient Information (3190)

Patient Problems Erosion (1750); Pain (1994); Scar Tissue (2060); Discomfort (2330); Dyspareunia (4505); Urinary Incontinence (4572)

Event Date 04/25/2018

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, the patient with this device experienced pain and dyspareunia.An exam revealed mesh erosion on right anterior vaginal wall, the surgical mesh arms were palpable, tender to palpation of bilateral sulci.In-office vaginoscopy was performed and confirmed 3-4 mm of mesh erosion on right anterior vaginal wall.Excision of right arm of the device was performed along with urethrolysis and closure of excision area dead space, closure of vaginal suburethral area, cystoscopy.Intraoperative findings revealed that the right arm of the surgical mesh noted to be quite distal and superficial to vaginal mucosa and distal along urethra (dissected/excised all the way under the inferior pubic rami at the level of obturator internus muscle).There was no evidence of erosion on left side.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation 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.

• 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: 13392044
• MDR Text Key: 284681810
• Report Number: 2125050-2022-00074
• 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: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5622687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 01/31/2022
• 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 Age: 47 YR
• Patient Sex: Female