MAUDE Adverse Event Report: SMART PRACTICE TRUE PATCH TEST; SYSTEM, DELIVERY, ALLERGEN AND VACCINE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Rash (2033); Tachycardia (2095); Burning Sensation (2146); Dizziness (2194); Sore Throat (2396); Numbness (2415); Shaking/Tremors (2515); Skin Disorders (4543)

Event Date 11/08/2021

Event Type  Injury  

Event Description

My dermatologist administered the smartpractice true patch test, all 3 panels.Immediately following initial application of panel 1, a visible skin reaction began to occur around panel.The same reaction followed application of subsequent panels.Panels were secured using paper tape.After leaving dermatology office (5-10 mins) i began to experience severe burning at panel site, rapid heart rate, shaking/jittery, numbness and tingling of tongue and lips, throat tightness, hoarseness, dizziness/lightheadedness, feeling like i might have diarrhea.I was able to make it to the nearest hospital where the triage rn noted a growing rash outside of panel site, high blood pressure, and dilated pupil in left eye, in addition to my other symptoms.The hospital removed the patch panels and administered pepcid, benadryl and prednisone.Fda safety report id# (b)(4).

• Brand Name: TRUE PATCH TEST
• Type of Device: SYSTEM, DELIVERY, ALLERGEN AND VACCINE
• Manufacturer (Section D): SMART PRACTICE
• MDR Report Key: 12820497
• MDR Text Key: 280901817
• Report Number: MW5105344
• Device Sequence Number: 1
• Product Code: LDH
• 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: 11/11/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Patient Sequence Number: 1
• Treatment: ELDERBERRY; SPRINTEC; VITAMIN C ; VITAMINS D3
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White