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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL MM II 75; FLOSS, DENTAL
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RANIR LLC PLACKERS PKFL MM II 75; FLOSS, DENTAL Back to Search Results
Model Number PKFL MM II 75
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tooth Fracture (2428)
Event Date 06/24/2021
Event Type  malfunction  
Event Description
Consumer left a voicemail: bought one of our products: micro mint flossers.Unfortunately it just broke one of his teeth.While he was flossing his teeth his top moral broke a little chip.First time he has seen it happen.He knows we have made some changes to them.The floss string is so hard, not like what he is used to.Old packages would sometimes break and were looser, but these are not breaking that easy and are very hard.When he tried to pull it out it broke part of it.He went to the dentist yesterday, they took an xray.They weren't sure how it happened.Couldn't find anything that caused the problem, it wasn't due to an issue with one of his other teeth.Has healthy teeth.
 
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Brand Name
PLACKERS PKFL MM II 75
Type of Device
FLOSS, DENTAL
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512 5353
MDR Report Key12182319
MDR Text Key264133658
Report Number1825660-2021-00981
Device Sequence Number1
Product Code JES
UDI-Device Identifier5108018751
UDI-Public5108018751
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 07/16/2021
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 NumberPKFL MM II 75
Device Lot Number0350C
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/24/2021
Initial Date Manufacturer Received 06/24/2021
Initial Date FDA Received07/16/2021
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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