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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC MANUAL TOOTHBRUSH
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RANIR, LLC MANUAL TOOTHBRUSH Back to Search Results
Device Problems Break (1069); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2014
Event Type  malfunction  
Event Description
The consumer stated that her daughter uses it and she is on the 3rd one within 7 months.The bite pads are breaking off at times due to her daughters heavy grinding and causing her to need a new one.
 
Manufacturer Narrative
Consumer stated that her daughter uses it and she is on the 3rd one within 7 months.The bite pads are breaking off at times due to her daughters heavy grinding and causing her to need a new one.
 
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Brand Name
MANUAL TOOTHBRUSH
Type of Device
MANUAL TOOTHBRUSH
Manufacturer (Section D)
RANIR, LLC
4701 east paris avenue se
grand rapids MI 49512
Manufacturer (Section G)
RANIR, LLC
4701 east paris avenue se
grand rapids MI 49512
Manufacturer Contact
paula bojsen
4701 east paris avenue se
grand rapids, MI 49512
6166988880
MDR Report Key4281383
MDR Text Key5032025
Report Number1825660-2014-00957
Device Sequence Number1
Product Code OBR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 11/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/28/2014
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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