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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC SHYN SMSNC PRO PLAT CLN II; TOOTHBRUSH, POWERED

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RANIR LLC SHYN SMSNC PRO PLAT CLN II; TOOTHBRUSH, POWERED Back to Search Results
Model Number SMSNC PRO PLAT CLN II SHYN BULK WHT
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  malfunction  
Event Description
Consumer stated "i stared using a new brush head and everytime i brush, i end up with a few bristles in my mouth.".
 
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Brand Name
SHYN SMSNC PRO PLAT CLN 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 stenske
6166988880
MDR Report Key10437467
MDR Text Key204523237
Report Number1825660-2020-00796
Device Sequence Number1
Product Code JEQ
UDI-Device Identifier00850003700854
UDI-Public850003700854
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 08/21/2020
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 NumberSMSNC PRO PLAT CLN II SHYN BULK WHT
Was Device Available for Evaluation? No
Distributor Facility Aware Date07/28/2020
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/21/2020
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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