MAUDE Adverse Event Report: THE FLEX COMPANYY FLEX; FLEX DISC

Model Number	PN 10005
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted the company's customer experience team via email to report a suspected systemic allergic reaction to flex disc.The customer inserted a flex disc for the very first time at approximately 2:15pm in the afternoon.At around 6pm she discovered that she had hives all over her body and felt her throat "closing up", so she took benadryl and went to the emergency room.The customer noted that she has eczema and a host of known allergies/sensitivities, including to strawberries, hummus, latex, and silicas found in some cosmetic products which causes severe pain if they come in contact with her skin.The customer also noted she had a severe allergy to cephalosporins, and stated that she had also previously experienced a stevens-johnson syndrome reaction after receiving a rocephin injection which caused her skin to peel from her scalp to her shoulders for months afterwards.The customer states that she removed her flex disc at the hospital at around 7 pm.Customer alleged that her symptoms began to improve within minutes after removal, but stated this could be due to the benadryl she had already taken.The customer also states that she received iv pepcid and iv steroids in the hospital, and was prescribed a course of oral prednisone, oral pepcid, and oral benadryl upon discharge from the emergency room.Following this event, the customer underwent airborne allergen testing.The only positive allergen reaction that came up was for dust mites.Based on the information gathered during this investigation, the allergy testing record provided by the customer, and her history of other severe allergies and reactions, the exact cause of this customer's allergic reaction cannot be determined.The submission of this report is not an admission by the company that the product in question caused or contributed to this event.

• Brand Name: FLEX
• Common Device Name: FLEX DISC
• Manufacturer (Section D): THE FLEX COMPANYY; 319 lincoln blvd.,; suite 200; venice, ca 90291
• Manufacturer Contact: jacqueline piscitello ; 319 lincoln blvd.; suite 200; california 90921 ; 7817997090
• MDR Report Key: 16251211
• Report Number: 3012971814-2023-00001
• Device Sequence Number: 17480506
• Product Code: HHE
• UDI-Device Identifier: 00850037498154
• UDI-Public: 850037498154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: PN 10005
• Device Lot Number: 54413
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female