MAUDE Adverse Event Report: WRIST BAND; ORTHOSIS, LIMB BRACE

Device Problem Product Quality Problem (1506)

Patient Problems Bacterial Infection (1735); Fungal Infection (2419); Muscle/Tendon Damage (4532); Localized Skin Lesion (4542)

Event Date 08/10/2020

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); support@giawellness.Com; (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.I felt a wart that i left untreated for several months until it grew too large to ignore.I went to a dermatologist to have it removed on (b)(6) 2018.I tested positive for gut infections of pathogenic bacteria and yeast on (b)(6) 2020, which my physician treated.I tested positive for ureaplasma in (b)(6) 2021, which my physician treated.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, and had to get prp again.Their consultant spoke with me on the phone for 25 minutes in (b)(6) 2022 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.I purchased a competing product that did not make medical claims in september 2021 and it worked in less than 24 hours.Fda safety report id# (b)(4).

• Brand Name: WRIST BAND
• Type of Device: ORTHOSIS, LIMB BRACE
• MDR Report Key: 15638701
• MDR Text Key: 302244934
• Report Number: MW5112763
• Device Sequence Number: 1
• Product Code: IQI
• 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
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: IH20 ACTIVATION SYSTEM COMBO-PACK, "98486"
• Patient Outcome(s): Disability
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic