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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS EF FL VIP 3PK; TOOTHBRUSH, POWERED

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RANIR LLC EQUATE BR HDS EF FL VIP 3PK; TOOTHBRUSH, POWERED Back to Search Results
Model Number BR HDS EF FL VIP 3PK
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
Consumer sent picture of the brush with and it appeared that a tuft of bristles had fallen out.
 
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Brand Name
EQUATE BR HDS EF FL VIP 3PK
Type of Device
TOOTHBRUSH, POWERED
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer (Section G)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
Manufacturer Contact
rebekah stenske
6166988880
MDR Report Key10317767
MDR Text Key202241407
Report Number1825660-2020-00786
Device Sequence Number1
Product Code JEQ
UDI-Device Identifier00681131129053
UDI-Public681131129053
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 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberBR HDS EF FL VIP 3PK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Distributor Facility Aware Date06/24/2020
Initial Date Manufacturer Received 06/24/2020
Initial Date FDA Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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