MAUDE Adverse Event Report: THE SUPER PATCH COMPANY LTD LLC. SUPERPATCH FLOW, DEFEND, VICTORY, FREEDOM; TAPE, ORTHOPEDIC

Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 i purchased several hundred dollars of superpatches which i received january 10th.On january 16th, i requested a full refund of my purchase price in accordance with the superpatch 30-day guarantee listed on the bill of purchase and on their website.I purchased the patches primarily for my wife.She is not overly sensitive, however after using the patch she experienced a severe skin reaction including redness and itching which persisted over 2 weeks after her severe reaction to the patch.She was treated with cortisone cream, but still the redness and itching persists.Her doctor advised to not rechallenge with the patch.I returned almost all the patches (she used only 2) yet the company has not refunded any money as of (b)(6) 2024.Based on my information, these patches are being sold as a cure for many ailments but are just stickers.It is classic pseudo-science.Ref report: mw5161566.

• Brand Name: SUPERPATCH FLOW, DEFEND, VICTORY, FREEDOM
• Common Device Name: TAPE, ORTHOPEDIC
• Manufacturer (Section D): THE SUPER PATCH COMPANY LTD LLC.
• MDR Report Key: 20532926
• Report Number: MW5161565
• Device Sequence Number: 19280455
• Product Code: HXT
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/28/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White