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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRUG DETECTION PATCH CONTAINER, SPECIMEN, STERILE

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DRUG DETECTION PATCH CONTAINER, SPECIMEN, STERILE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 06/01/2019
Event Type  Injury  
Event Description
I had an allergic reaction to a drug detection patch that was applied by a social worker who wasn't qualified at that time to apply one. Went to e. R. Within an hour of patch applied. I went home on medication and returned to e. R. The next evening and had to have an epi pen administered to live. I told the courts and social worker ((b)(6)) of (b)(6) and they laughed at me. I just don't want this to happen to anyone else and have given my medical documents to dhs in (b)(6) over a year ago and i want to make sure the social worker followed the laws and reported this to the fda as mandated. If not i would be more than happy to give you the medical documentation referring to this matter. Fda safety report id# (b)(4).
 
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Brand NameDRUG DETECTION PATCH
Type of DeviceCONTAINER, SPECIMEN, STERILE
MDR Report Key10927475
MDR Text Key219153927
Report NumberMW5098160
Device Sequence Number1
Product Code FMH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/30/2020 Patient Sequence Number: 1
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