Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC PLACKERS KDS DUAL GRP FR SMTH 75; FLOSS, DENTAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RANIR LLC PLACKERS KDS DUAL GRP FR SMTH 75; FLOSS, DENTAL Back to Search Results
Model Number PKFL KDS DUAL GRP FR SMTH 75
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Itching Sensation (1943)
Event Date 05/06/2019
Event Type  malfunction  
Event Description
Reporter stated that her child is allergic to pineapple and her child reacted almost immediately after using the product.She immediately had an itchy tongue and face upon contact with the product.She is almost 11 and pineapple is her only allergy.The symptoms lasted about 30 minutes and were rectified with benadryl.Product was returned for review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PLACKERS KDS DUAL GRP FR SMTH 75
Type of Device
FLOSS, DENTAL
Manufacturer (Section D)
RANIR LLC
4701 east paris ave. se
grand rapids MI 49512
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 Key8693476
MDR Text Key148427680
Report Number1825660-2019-00572
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 06/12/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2019
Distributor Facility Aware Date05/24/2019
Initial Date Manufacturer Received 05/24/2019
Initial Date FDA Received06/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-