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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC EQUALINE FLSP CRV UNF HT 90; FLOSS, DENTAL
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RANIR LLC EQUALINE FLSP CRV UNF HT 90; FLOSS, DENTAL Back to Search Results
Model Number FLSP CRV UNF HT 90
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 08/05/2018
Event Type  malfunction  
Event Description
Consumer called the retailer asking why the product breaks.He stated that he has noticed that sometimes when he uses the pick, a piece of it will break off.He stated that usually he catches it and spits it out, however sometimes he is not able to find the piece that broke off.He would like to know if it's dangerous and if he has update: consumer guessed that maybe 1/8th of an inch would break off.Sometimes he would re-use the flosser, it depends.Consumer no longer had the broken flossers to return.
 
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Brand Name
EQUALINE FLSP CRV UNF HT 90
Type of Device
FLOSS, DENTAL
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 Key7822453
MDR Text Key118556857
Report Number1825660-2018-00393
Device Sequence Number1
Product Code JES
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 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberFLSP CRV UNF HT 90
Was Device Available for Evaluation? No
Distributor Facility Aware Date08/05/2018
Date Manufacturer Received08/05/2018
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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