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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RANIR LLC KROGER MNTB MLTACT MASS SO; TOOTHBRUSH, MANUAL
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RANIR LLC KROGER MNTB MLTACT MASS SO; TOOTHBRUSH, MANUAL Back to Search Results
Model Number MNTB MLTACT MASS SO 10PK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Swelling (2091); Tachycardia (2095)
Event Date 06/10/2019
Event Type  malfunction  
Event Description
Consumer stated she had a "reaction" within 5 minutes of using this product.Her tongue swelled, heart was racing, itching.Symptoms lasted for 3 hours.She used the same toothpaste she always uses, this was her first time using this kind of toothbrush.Consumer has a known latex allergy and other food allergies but nothing she else that she is aware.
 
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Brand Name
KROGER MNTB MLTACT MASS SO
Type of Device
TOOTHBRUSH, MANUAL
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 Key8772947
MDR Text Key150566728
Report Number1825660-2019-00581
Device Sequence Number1
Product Code EFW
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 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberMNTB MLTACT MASS SO 10PK
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/10/2019
Date Manufacturer Received06/10/2019
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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