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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC REPLACEMENT BRUSH HEAD; POWER TOOTHBRUSH REPLACEMENT BRUSH HEAD
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RANIR LLC REPLACEMENT BRUSH HEAD; POWER TOOTHBRUSH REPLACEMENT BRUSH HEAD Back to Search Results
Device Problem Sticking (1597)
Patient Problem No Code Available (3191)
Event Date 09/09/2015
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted because after reviewing complaint to close, it was determined that the consumer report did not indicate which action occurred first; the bristles getting caught in the consumer's teeth or the bristles coming out of the toothbrush.In the event that the device malfunctioned (e.G.Bristles fell out) this could be a reportable event.If as originally thought, the bristles caught in the consumer's teeth due to his existing condition/tooth spacing, and then were pulled out of the brush, this would probably not be reportable.
 
Event Description
Bristles of toothbrush got caught in teeth and came out of brush.
 
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Brand Name
REPLACEMENT BRUSH HEAD
Type of Device
POWER TOOTHBRUSH REPLACEMENT BRUSH HEAD
Manufacturer (Section D)
RANIR LLC
4701 east paris se
grand rapids MI 49512 5353
Manufacturer (Section G)
RANIR LLC
4701 east paris se
grand rapids MI 49512 5353
Manufacturer Contact
elsa baker
4701 east paris ave se
grand rapids, MI 49512-5353
6166988880
MDR Report Key5240388
MDR Text Key32059134
Report Number1825660-2015-00096
Device Sequence Number1
Product Code JEQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Device Unattended
Remedial Action Replace
Type of Report Initial
Report Date 10/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Device Unattended
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Home
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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