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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC SMARTLY MNTB BULLSEYE SO 2PK; TOOTHBRUSH, MANUAL
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RANIR LLC SMARTLY MNTB BULLSEYE SO 2PK; TOOTHBRUSH, MANUAL Back to Search Results
Model Number MNTB BULLSEYE SO 2PK PNK
Device Problem Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2020
Event Type  malfunction  
Event Description
Consumer left review on retailer website: i purchased a few packs of these because i thought they were cute.What motivated me to write this review, however, was that within the first three days of using one of them a massive amount of the bristles came out (again, i gave them the benefit of the doubt and attributed that to over-brushing) until i noticed that small metal pieces (i'm assuming what holds the bristles in place) has come out both in my sink and in my mouth.Then my best friend told me the same thing had happened to her!!" no contact info for consumer and no returned product.
 
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Brand Name
SMARTLY MNTB BULLSEYE SO 2PK
Type of Device
TOOTHBRUSH, MANUAL
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 Key10248404
MDR Text Key202954112
Report Number1825660-2020-00781
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 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMNTB BULLSEYE SO 2PK PNK
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/10/2020
Date Manufacturer Received06/10/2020
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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