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 Pain (1994); Abnormal Vaginal Discharge (2123); Sexual Dysfunction (4510); Implant Pain (4561)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

This mdr is created as an additional follow-up to mdr record # 125050-2018-00833, initially reported on 21-nov-2018 through esubmitter.This mdr is to reflect the additional information received.According to the available information, the patient's legal representative stated severe pain with daily activities and intercourse.Altis was implanted on (b)(6) 2016 and excised on (b)(6) 2016.Corrective action: management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

As reported to coloplast, though not verified, additional information received on 04/23/2021.(b)(6) 2016 - erosion altis revision.(b)(6) 2016 - ongoing pelvic pain and dyspareunia s/p altis/coloplast revision, states continues to leak urine with valsalva activities, bulge has returned, states has not been the same since surgeries and is greatly affecting the quality of her life, states she desires to have altis/coloplast removed.Thick scar band (tender to palpation) in area of altis with poorly visualized area of erosion, grade 2 cystocele with loss of apical support.Urinary leakage with cough/sneeze, vaginal discharge, unable to have intercourse due to dyspareunia.Vaginal exposure of altis, pelvic pain.(b)(6) 2016 - partial excision of altis, anterior repair.Intraoperative findings: previously palpated thick scar band was contiguous with altis, most distal edge of altis found to be 4 cm from urethral meatus over lower portion of bladder, ~1 x 1 cm midline altis erosion, small amount of ecchymosis on left lateral side of bladder due to close proximity of altis.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: 12305509
• MDR Text Key: 266032354
• Report Number: 2125050-2021-01135
• 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: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54