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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVS HEALTH/KAZ USA, INC., A HELEN OF TROY COMPANY ACCU-HEAT SERIES 300 VINYL HEATING PAD; PAD, HEATING, POWERED
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CVS HEALTH/KAZ USA, INC., A HELEN OF TROY COMPANY ACCU-HEAT SERIES 300 VINYL HEATING PAD; PAD, HEATING, POWERED Back to Search Results
Model Number MHP716S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Irritation (1941); Electric Shock (2554)
Event Date 10/16/2020
Event Type  Injury  
Event Description
I recently purchased a (b)(6) health series 300 vinyl heating pad on (b)(6) 2020 from a (b)(6) pharmacy.I've used the heating pad to relieve lower back pain 1-2x per week.This past friday ((b)(6) 2020) i was laying down with the heating pad positioned again on my lower back, when suddenly i got an electrical shock from the heating pad.It felt like i was being electrocuted.I couldn't jump off the bed fast enough.Afterwards, my skin seemed irritated as if i was burned or the nerves were affected.Although i am fine now, i thought i should bring this to your attention.Fda safety report id # (b)(4).
 
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Brand Name
ACCU-HEAT SERIES 300 VINYL HEATING PAD
Type of Device
PAD, HEATING, POWERED
Manufacturer (Section D)
CVS HEALTH/KAZ USA, INC., A HELEN OF TROY COMPANY
MDR Report Key10740118
MDR Text Key213473363
Report NumberMW5097466
Device Sequence Number1
Product Code IRT
UDI-Device Identifier5042858870
UDI-Public5042858870
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/23/2020
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? Yes
Device Operator Lay User/Patient
Device Model NumberMHP716S
Device Catalogue NumberSERIES 300
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/26/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age55 YR
Patient Weight75
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