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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFRARED &LYMPHATIC DRAINAGE BODY WRAP LAMP, INFRARED, THERAPEUTIC HEATING

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INFRARED &LYMPHATIC DRAINAGE BODY WRAP LAMP, INFRARED, THERAPEUTIC HEATING Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Headache (1880); Numbness (2415)
Event Date 03/27/2021
Event Type  Injury  
Event Description
I bought a (b)(6) for a lymphatic body wrap at (b)(6) with esthetician (b)(6). After wrap was in place, i was left unattended for about 25 minutes unable to move and control the pressure of the wrap left with some bruising and numbing in my arms. With post tingling and headache. Esthetician said she would get the machine looked at and postpone appointments that day. Fda safety report id# (b)(4).
 
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Brand NameINFRARED &LYMPHATIC DRAINAGE BODY WRAP
Type of DeviceLAMP, INFRARED, THERAPEUTIC HEATING
MDR Report Key11596296
MDR Text Key243613151
Report NumberMW5100440
Device Sequence Number1
Product Code ILY
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
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: 03/30/2021 Patient Sequence Number: 1
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