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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS PKFL MM II 150; FLOSS, DENTAL
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RANIR LLC PLACKERS PKFL MM II 150; FLOSS, DENTAL Back to Search Results
Model Number PKFL MM II 150
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Swelling (2091); Numbness (2415)
Event Date 11/13/2018
Event Type  Injury  
Event Description
Consumer used the product once and claimed that he had a reaction after using this product."the left side of my lips went numb and swelled up.No idea why only in that spot and not all of my lips since i cleaned all my teeth.My only allergy is contrast dye and i¿d be sunrised if that ingredient is present in this product.I am going to try this again tomorrow night to see if i get the same reaction as this evening." consumer said he used it again and had the same symptoms.
 
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Brand Name
PLACKERS PKFL MM II 150
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 Key8130764
MDR Text Key129295596
Report Number1825660-2018-00457
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 12/04/2018
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 MM II 150
Was Device Available for Evaluation? No
Distributor Facility Aware Date11/13/2018
Initial Date Manufacturer Received 11/13/2018
Initial Date FDA Received12/04/2018
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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