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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONAIR LLC. CONAIR; ELECTRIC TOOTHBRUSH

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CONAIR LLC. CONAIR; ELECTRIC TOOTHBRUSH Back to Search Results
Model Number RTGX
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/10/2023
Event Type  Injury  
Manufacturer Narrative
On 8/30/2023 - we have requested the device be returned to the manufacturer for an investigation.To date, we have not received the device.
 
Event Description
On (b)(6) 2023 - the consumer claim to have cut her lip and had bruising while in use of the product.Medical attention was not received.
 
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Brand Name
CONAIR
Type of Device
ELECTRIC TOOTHBRUSH
Manufacturer (Section D)
CONAIR LLC.
1 cummings point rd.
stamford CT 06902
Manufacturer Contact
1 cummings point rd.
stamford, CT 06902
MDR Report Key17682325
MDR Text Key322620312
Report Number1222304-2023-00020
Device Sequence Number1
Product Code JEQ
UDI-Device Identifier85452000105
UDI-Public85452000105
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 Other
Type of Report Initial
Report Date 08/10/2023
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? No
Device Model NumberRTGX
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/05/2023
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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