MAUDE Adverse Event Report: SMART SLEEVE SET GIA WELLNESS; STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)

Model Number 39255

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/01/2019

Event Type  Injury  

Event Description

I ordered several gia wellness products (www.Giawellness.Com) in 2018 - 2019 and obtained gia wellness's consultant information from my physician, who used their products.My doctor said she felt better using gia wellness products but that she recommends that patients prioritize working on themselves before buying emf protection products.I called the gia wellness consultant to learn more (b)(6).She sent me links to the science of how the device works, youtube videos and testimonials.She invited me to a private facebook group where people make medical claims about gia products.I purchased several products from 3/25/2018 through 3/29/2019.My physician administered platelet rich plasma (prp) on (b)(6) 2019.I wore gia wellness wrist and elbow bands to help the recovery.My tendonitis flared up in (b)(6) 2019 when i performed my own office move, lifting 5 - 10 pounds of files and books over an hour.I had taken rest from almost all physical activities of daily living since (b)(6) 2019.I got prp again in (b)(6) 2020 through a different physician and used incrediwear that my physician recommended.My arms recovered in two weeks and i continued to improve over the next few months and was able to perform most normal activities, such as food preparation, carrying groceries and cleaning my own laundry.Their consultant spoke with me on the phone for 25 minutes in (b)(6) 2021 telling me how she has seen it cure infections, including aids, and accelerate healing from physical injuries.She runs a facebook page full of testimonials from people making medical claims about gia wellness products.She said to continue using the products to allow them to work, even though i told her that they had not worked after 3 years of use.I posted reviews on the gia wellness describing how the devices did not work for me at all and that i purchased all their products, giving them 3 years to work.I would have left it alone, except that the company deleted my negative reviews on the multiple products i purchased and now other patients will not be informed.Physician used live ultrasound visualization to direct prp injection to visible tears.Fda safety report id# (b)(4).

• Brand Name: SMART SLEEVE SET GIA WELLNESS
• Type of Device: STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS)
• MDR Report Key: 15633204
• MDR Text Key: 302179395
• Report Number: MW5112744
• Device Sequence Number: 1
• Product Code: DWL
• 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: 10/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 39255
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LIOTHYRONINE; TESTOSTERONE
• Patient Outcome(s): Disability
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic