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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC LIFE BRAND FLSP CMPCT MNT HT 150 CA; FLOSS, DENTAL
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RANIR LLC LIFE BRAND FLSP CMPCT MNT HT 150 CA; FLOSS, DENTAL Back to Search Results
Model Number FLSP CMPCT MNT HT 150 CA
Device Problems Product Quality Problem (1506); Failure to Select Signal (1582)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/14/2021
Event Type  Injury  
Event Description
Consumer stated: they used lifebrand for first time and it cut through cx's molar.Flosser is terrible, rough quality, and it got stuck so cx had to pull it and it took off the filling from the tooth cx is unhappy as it hurt her and she has to go the dentist now.1st one she used got stuck in her molars and she couldn't do anything.She usually flosses and has no issue.It took a while to get it out, tried little scissors, but that didn't work, and she pulled it out and in the process of doing so it broke her filling.
 
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Brand Name
LIFE BRAND FLSP CMPCT MNT HT 150 CA
Type of Device
FLOSS, DENTAL
Manufacturer (Section D)
RANIR LLC
4701 east paris avenue se
grand rapids MI 49512 5353
MDR Report Key12313563
MDR Text Key266227136
Report Number1825660-2021-00991
Device Sequence Number1
Product Code JES
UDI-Device Identifier00057800908876
UDI-Public057800908876
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 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberFLSP CMPCT MNT HT 150 CA
Device Lot Number0290R
Was Device Available for Evaluation? No
Distributor Facility Aware Date07/14/2021
Initial Date Manufacturer Received 07/14/2021
Initial Date FDA Received08/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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