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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS DNTL BR MNT 4CT CA; TOOTHBRUSH, MANUAL

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RANIR LLC PLACKERS DNTL BR MNT 4CT CA; TOOTHBRUSH, MANUAL Back to Search Results
Model Number DNTL BR MNT 4CT CA
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2020
Event Type  malfunction  
Event Description
Consumer called in about plackers interdental brushes mint blast.They work well in the tooth area but she cant get through her whole mouth without the brush breaking off.Its expensive to use only one without it breaking.Product was not returned for review.
 
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Brand Name
PLACKERS DNTL BR MNT 4CT CA
Type of Device
TOOTHBRUSH, MANUAL
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 Key10164847
MDR Text Key199897479
Report Number1825660-2020-00777
Device Sequence Number1
Product Code EFW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDNTL BR MNT 4CT CA
Was Device Available for Evaluation? No
Distributor Facility Aware Date05/29/2020
Date Manufacturer Received05/29/2020
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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