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); Incontinence (1928); Nerve Damage (1979); Pain (1994); Pocket Erosion (2013); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Discomfort (2330); Injury (2348); No Code Available (3191)

Event Date 04/25/2018

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

As reported to coloplast though not verified, the patient's legal representative stated the mesh had eroded into vagina.The patient suffered serious bodily injuries, including unabated an incurable erosion, pain, discomfort, pressure, difficulty voiding urine, continued incontinence, scarring, dyspareunia, nerve injury and the need for future treatments including surgery.

Manufacturer Narrative

This follow up mdr is created to document the additional device information.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Manufacturer Narrative

This follow-up was created to document the additional event information and updated explant date.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 from medical records stated the mesh was removed on (b)(6) 2019.Partial removal of the "exposed" mesh occurred on (b)(6) 2018.

Manufacturer Narrative

H6 patient code 3191 - addtiional information "diffuse trabeculations in bladder.".

Event Description

Additional information, as reported to coloplast though not verified, indicated: on (b)(6) 2018 - in-office tightening of altis/coloplast with tightening sutures, then pushed incision line toward pelvic sidewall to cut tightening sutures.On (b)(6) 2018 - suture and small area of mesh erosion over incision.On (b)(6) 2018 - exposed mesh 2-3 mm, suture still in place, vaginal discharge, uti.On (b)(6) 2018 - mesh exposure.On (b)(6) 2018 - cystoscopy and excision of eroded vaginal mesh (general anesthesia), intraop findings: the left side required a little bit of work because of some granulation tissue growing already, able to dissect about 1 cm bilaterally.On (b)(6) 2018 - recurrent uti, continued mesh exposure on right side; mesh excised in office.On (b)(6) 2019 - mesh erosion 3-4 mm, oab, diffuse trabeculations in bladder.On (b)(6) 2019 - incontinence.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9903156
• MDR Text Key: 188368916
• Report Number: 2125050-2020-00294
• 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: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/01/2020

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: 5622687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/04/2020; 03/04/2020; 03/04/2020
• Supplement Dates FDA Received: 05/07/2020; 06/01/2020; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 47 YR