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U.S. Department of Health and Human Services

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

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RANIR LLC SHYN SMSNC PRO ADV CLN; TOOTHBRUSH, POWERED Back to Search Results
Model Number SMSNC PRO ADV CLN ASY SHYN BULK WHT
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
Consumer stated he/she "used the brush for two days now.My concern is that every time i've brushed, i end up with a stray bristle in my mouth.The first brushing was the worst- a mouthful of loose bristle- but i'm still experiencing a few in my mouth each time." requested the product back but it was not returned.
 
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Brand Name
SHYN SMSNC PRO ADV CLN
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 Key9507106
MDR Text Key178751362
Report Number1825660-2019-00679
Device Sequence Number1
Product Code JEQ
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 12/20/2019
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 ADV CLN ASY SHYN BULK WHT
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/26/2019
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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