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

Model Number 5196502400

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Urinary Tract Infection (2120); Discharge (2225); Deformity/ Disfigurement (2360); Intermenstrual Bleeding (2665); No Information (3190); No Code Available (3191)

Event Date 06/27/2018

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 legal representative stated severe pelvic pain, urinary urgency problems, incontinence, infections and difficulty with daily activities, emotional pain and injury.Patient has suffered and will suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge and multiple corrective surgeries.Operations to locate and remove mesh, attempt to repair pelvic organs, tissue and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spine and the vagina and operations to remove portions of the female genitalia.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

Additional information received further reported recurring urinary tract infections and a folded sling on the left.

Event Description

Additional information received on 1/29/2023 states that the patient on (b)(6) 2018 was experiencing bleeding.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis, mn
• Manufacturer Contact: brian schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 6128671177
• MDR Report Key: 10139254
• MDR Text Key: 194671030
• Report Number: 2125050-2020-00421
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Female