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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC DONTODENT EF II; TOOTHBRUSH, POWERED

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RANIR LLC DONTODENT EF II; TOOTHBRUSH, POWERED Back to Search Results
Model Number EF II BULK TRAY GRN
Device Problem Degraded (1153)
Patient Problem Insufficient Information (4580)
Event Date 01/28/2021
Event Type  malfunction  
Event Description
Ran2021/62 aufsteckbürsten active clean young unsere beiden söhne benutzen beide die zahnbürste dontodent aktive young.Wir kaufen dazu immer die passenden aufsätze im 3er pack.Allerdings verlieren die aufsätze in letzter zeit die bürstenhaare.Translation: our two sons both use the toothbrush dontodent active young.We always buy the matching attachments in a pack of 3.However, the attachments have been losing brush hair recently.
 
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Brand Name
DONTODENT EF II
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 hamilton
6166988880
MDR Report Key11426766
MDR Text Key244191842
Report Number1825660-2021-00915
Device Sequence Number1
Product Code JEQ
UDI-Device Identifier00681131129053
UDI-Public681131129053
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/05/2021
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 NumberEF II BULK TRAY GRN
Was Device Available for Evaluation? No
Distributor Facility Aware Date01/28/2021
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received03/07/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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