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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 WM50FF
Device Problem Fire (1245)
Patient Problem Burn(s) (1757)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
On (b)(6) 2021 - the consumer requested a replacement device and does not want a claim submitted. Therefore the device will not be returned and an investigation will not take place.
 
Event Description
On (b)(6) 2021 - the consumer has submitted this incident on behalf of this wife. The consumer claims the product caught on fire and his wife received a burn. The incident occurred over a year ago and the consumer does not want to file a claim but wants 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 06902
MDR Report Key11560698
MDR Text Key241977162
Report Number1222304-2021-00012
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberWM50FF
Was Device Available for Evaluation? No Answer Provided
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: 03/24/2021 Patient Sequence Number: 1
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