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U.S. Department of Health and Human Services

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

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SMART PRACTICE TRUE PATCH TEST; SYSTEM, DELIVERY, ALLERGEN AND VACCINE Back to Search Results
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).
 
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Brand Name
TRUE PATCH TEST
Type of Device
SYSTEM, DELIVERY, ALLERGEN AND VACCINE
Manufacturer (Section D)
SMART PRACTICE
MDR Report Key12820497
MDR Text Key280901817
Report NumberMW5105344
Device Sequence Number1
Product Code LDH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/15/2021
Patient Sequence Number1
Treatment
ELDERBERRY; SPRINTEC; VITAMIN C ; VITAMINS D3
Patient Outcome(s) Hospitalization; Life Threatening;
Patient Age34 YR
Patient SexFemale
Patient Weight44 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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