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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC EQUATE BR HDS EF FL VIP 3PK; TOOTHBRUSH, POWERED

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RANIR LLC EQUATE BR HDS EF FL VIP 3PK; TOOTHBRUSH, POWERED Back to Search Results
Model Number BR HDS EF FL VIP 3PK
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/06/2019
Event Type  malfunction  
Event Description
Customer called because the plastic bristles kept falling off on the eq tbp flseff rf 3ct.The purple plastic pieces are coming off as she using them and she claims to have swallowed one of them on 6/11.The bristles were coming out of all 3 of the brush heads.She decided to call after it happened with the third one.She used the last one about 2 weeks.Reviewed trend for the given product and noted no other complaints in the last 12 months for tpe coming out on brush head.
 
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Brand Name
EQUATE BR HDS EF FL VIP 3PK
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
4701 east paris ave. se
grand rapids, MI 49512-5353
6166988880
MDR Report Key8768200
MDR Text Key150567929
Report Number1825660-2019-00579
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 07/08/2019
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 NumberBR HDS EF FL VIP 3PK
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/11/2019
Initial Date Manufacturer Received 06/11/2019
Initial Date FDA Received07/08/2019
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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