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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR, LLC NOT PROVIDED; MANUAL TOOTHBRUSH
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RANIR, LLC NOT PROVIDED; MANUAL TOOTHBRUSH Back to Search Results
Device Problem Component Falling (1105)
Patient Problem No Information (3190)
Event Date 08/11/2014
Event Type  malfunction  
Event Description
I bought some toothbrushes and the bristles are falling out.
 
Manufacturer Narrative
This complaint has not been confirmed.Device not returned to manufacturer, and no lot number information was given so an evaluation cannot be performed as to the root cause or actual nature of the problem.No injury was reported, no medical attention was reported to have been sought.This is being reported because there is a possibility that toothbrush bristles may require medical intervention in order to remove them if swallowed.
 
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Brand Name
NOT PROVIDED
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 Key4086234
MDR Text Key4825348
Report Number1825660-2014-00906
Device Sequence Number1
Product Code EFW
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 08/27/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/11/2014
Initial Date FDA Received09/12/2014
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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