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 Edema (1820); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, though not verified, medwatch: mw5096174: inflammation and nerve issues; in 2018, the patient had anterior and posterior colporrhaphy for repair of a cystocele and rectocele and placement of a mid-urethral sling.The surgeon used coloplast axis tutoplast and coloplast altis for the repair.A month or two after the procedure, the patient began to experience swelling and/or edema in my hands which later spread through their entire body.In addition to the swelling, the patient also had tingling their hands, arms, legs and feet.Numbness, electrical shocks, decreased range of motion, decreased strength, muscle spasms and muscle rigidity, a blue/purple color to their arms, legs and feet that is not cold related, heat intolerance and many more issues.The patient has also had constant high wbc, platelet and c-reactive protein.In 2018, the patient also had a vaginal vault suspension and hysterectomy due to further prolapse issues.Since that time period, the patient has been tested for more auto-immune disorders than knew existed.The patient had been treated by rheumatologist, neurologists, neuro-ophthalmologists, hematologists, and endocrinologists, both locally and at the clinic.All have agreed that there is something going on, they just do not know what is going.Most recently, the patient was diagnosed with hashimoto¿s which would account for some symptoms, but not all.Wbc and platelets have stayed around this number since the 2018 surgery.

• 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: usrll rachel lloyd ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 10788437
• MDR Text Key: 214728308
• Report Number: 2125050-2020-01043
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2020

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: No Information
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1