MAUDE Adverse Event Report: PLANTAR FASCILITIS GEL ARCH SUPPORT ; INSOLES, MEDICAL

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Burning Sensation (2146)

Event Date 10/26/2019

Event Type  Injury  

Event Description

I had purchased a private label product of (b)(6).It was their plantar fascilitis gel arch sleeves.The product indicated it is hypoallergenic and not made with natural latex products.I followed directions and wore them on saturday.I took them off as directed.Shortly thereafter, i developed severe rash specifically in the arches of my feet where they were worn.Large welts, burning, and blisters.I recruit physicians and was at a medical conferences so got advice from medical professionals.I had to use larger doses of oral benadryl, zyrtec, multiple topical creams and ice to get any sort of relief.A nurse suggested that i report this reaction to the product to your organization.They touted this product as hypoallergenic.I spoke with (b)(6) pharmacist to see if he could point me in direction of who to speak with in (b)(6) about this product and to get an idea of what was in this.I attempted to call the (b)(6) 800 number with no luck how to report and find out details of this product.The answer i got was bring it back for a refund.Fda safety report id# (b)(4).

• Brand Name: PLANTAR FASCILITIS GEL ARCH SUPPORT
• Type of Device: INSOLES, MEDICAL
• MDR Report Key: 9271868
• MDR Text Key: 165226766
• Report Number: MW5090854
• Device Sequence Number: 1
• Product Code: KYS
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 84