MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC ALTIS SLING 519650; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Edema (1820); Muscle Spasm(s) (1966); Loss of Range of Motion (2032); Swelling (2091); Numbness (2415); Test Result (2695); No Code Available (3191)

Event Date 05/07/2018

Event Type  Injury  

Event Description

Inflammation and nerve issues; on (b)(6) 2018, i had anterior and posterior colporrhaphy for repair of a cystocele and rectocele and placement of a midurethral sling.The surgeon used coloplast axis tutoplast and coloplast altis for the repair.A month or two after the procedure, i began to experience swelling and/or edema in my hands which later spread through my entire body.In addition to the swelling, i also had tingling in my hands, arms, legs and feet, numbness, electric shocks, decreased range of motion, decreased strength, muscle spasms and muscle rigidity, a blue/purple color to my arms, legs and feet that is not cold related, heat intolerance, and many more issues.I have also had constant high wbc, platelet and c-reactive protein.In (b)(6) 2018, i also had a vaginal vault suspension and hysterectomy due to further prolapse issues.Since that time period, i have been tested for more auto-immune disorders than i knew existed.I had been treated by rheumatologist, neurologists, neuro-ophthalmologists, hematologists and endocrinologists, both locally and at the (b)(6) clinic.All have agreed that there is something going on, they just do not know what is going.Most recently, i was diagnosed with hashimoto's which would account for some symptoms, but not all.Wbc and platelets have stayed around this number since the (b)(6) 2018 surgery; axis allograft dermis.Fda safety report id# (b)(4).

• Brand Name: ALTIS SLING 519650
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): COLOPLAST MANUFACTURING US, LLC
• MDR Report Key: 10436550
• MDR Text Key: 204195008
• Report Number: MW5096174
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/19/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 83