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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR CORPORATION CONAIR MASSAGER

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CONAIR CORPORATION CONAIR MASSAGER Back to Search Results
Model Number BM1RLF
Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)
Patient Problem Insufficient Information (4580)
Event Date 04/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6) 2021 - the consumer accepted a replacement product and will not be returning the product to the manufacturer for an investigation.
 
Event Description
(b)(6) 2021 - the consumer claims the remote on the product had an electrical smell and the remote on the unit burned. The consumer accepted a replacement.
 
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Brand NameCONAIR
Type of DeviceMASSAGER
Manufacturer (Section D)
CONAIR CORPORATION
1 cummings point rd.
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06614
MDR Report Key12128785
MDR Text Key262635786
Report Number1222304-2021-00019
Device Sequence Number1
Product Code MNW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBM1RLF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/07/2021 Patient Sequence Number: 1
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