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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL KDS DUAL GRP FR SMTH; FLOSS, DENTAL
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RANIR LLC PLACKERS PKFL KDS DUAL GRP FR SMTH; FLOSS, DENTAL Back to Search Results
Model Number PKFL KDS DUAL GRP FR SMTH 75
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Nausea (1970); Malaise (2359); Reaction (2414)
Event Date 02/04/2021
Event Type  Injury  
Event Description
My daughter used the plackers kids dual gripz, fruit smoothie swirl once.Then she became sick like she does with her allergic reaction.She is allergic to strawberries.Does this product contain strawberries? could it have come in contact with something that does contain strawberries? daughter had the reaction within 3 minutes of using the first one.No more flossers have been used.Her symptoms were nausea (normally the first sign of her reaction) and felt wrong.She told me she was feeling bad.The symptoms lasted about an hour.No medical attention was sought from a doctor.The mother treated her with benadryl.They typically use the mint flossers; this was the first time using the fruit smoothie.
 
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Brand Name
PLACKERS PKFL KDS DUAL GRP FR SMTH
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 hamilton
6166988880
MDR Report Key11423679
MDR Text Key242169431
Report Number1825660-2021-00914
Device Sequence Number1
Product Code JES
UDI-Device Identifier51080114516
UDI-Public51080114516
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 03/05/2021
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 NumberPKFL KDS DUAL GRP FR SMTH 75
Device Lot Number0216T
Was Device Available for Evaluation? No
Distributor Facility Aware Date02/04/2021
Initial Date Manufacturer Received 02/04/2021
Initial Date FDA Received03/05/2021
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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