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

Model Number 5196502400

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Distress (2329); Hematuria (2558); Genital Bleeding (4507); Urinary Incontinence (4572)

Event Type  Injury  

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

Event Description

As reported to coloplast, though not verified, the patient experienced significant mental and physical pain and suffering, emotional distress, disability, impairment, and loss of enjoyment of life.The patient underwent excision surgery, hospitalization, and other invasive treatment.It was noted that the patient will continue to require future medical treatment because certain injuries are permanent in nature.

Manufacturer Narrative

The lot # was reviewed for complaint trend, nonconforming report and capa.There were no nonconforming reports nor capa identified associated with this lot.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received on 9/26/2022 as follows: beginning 3(b)(6) 2017 vaginal spotting, ua positive for leukocytes, urgency, positive ua, possible mesh erosion.More urgency post op.Mesh palpable beneath the urethra centrally.Urgency, mesh exposure, pain.Urgency, mesh is palpable at the midline with mild tenderness.Hematuria, stress incontinence, mesh erosion.Excision of extruded vaginal mesh (altis) under lma.Pink-tinged urine, urge incontinence.Cystoscopy for microscopic hematuria and stress incontinence.Microscopic hematuria, mixed incontinence.

• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15198854
• MDR Text Key: 297597043
• Report Number: 2125050-2022-00773
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 05708932467407
• 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,Followup
• Report Date: 10/05/2022

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: Lay User/Patient
• Device Expiration Date: 10/14/2019
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 5124770
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2016
• 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 Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Sex: Female