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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC UP&UP BR HDS SMSNC II 3PK; TOOTHBRUSH, POWERED

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RANIR LLC UP&UP BR HDS SMSNC II 3PK; TOOTHBRUSH, POWERED Back to Search Results
Model Number BR HDS SMSNC II 3PK
Device Problem Positioning Problem (3009)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/13/2021
Event Type  malfunction  
Event Description
112386779 guest says this item injured her teeth she ended up getting a chip from this item not staying in place as advertised.Contact info not provided, product not returned.
 
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Brand Name
UP&UP BR HDS SMSNC II 3PK
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
MDR Report Key12258928
MDR Text Key266494843
Report Number1825660-2021-00986
Device Sequence Number1
Product Code JEQ
UDI-Device Identifier00071031584524
UDI-Public071031584524
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 08/02/2021
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 Operator Lay User/Patient
Device Model NumberBR HDS SMSNC II 3PK
Was Device Available for Evaluation? No
Distributor Facility Aware Date07/13/2021
Initial Date Manufacturer Received 07/13/2021
Initial Date FDA Received08/02/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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