MAUDE Adverse Event Report: RANIR LLC CARE ONE MNTB ORB BRIL WH ME 2PK; TOOTHBRUSH, MANUAL

Model Number MNTB ORB BRIL WH ME 2PK

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Tingling (2171)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

Consumer called and stated "there is something wrong with the plastic and ingredients you are using to make the toothbrushes.I got an allergic reaction after using the toothbrush - i was using it for 5 days to a week and each time after using it, i will break out.When i stopped using it, the break out stopped.I think i was breaking out from the actual plastic of the toothbrush head.Used the toothbrush for a few days, noticed her lips were becoming dry and cracked and her tongue started to become tingly.As soon as she stopped using the brush she noticed the symptoms started to go away.It took a couple days for the tingling to stop but it did go away." consumer had no changes in routine, same toothpaste as before.Consumer has a known latex allergy, however latex is not used in the manufacture of the product.When she has contact with latex her lips become very dry, she has never had tongue tingling.The same issues happen when she uses solo cups.

• Brand Name: CARE ONE MNTB ORB BRIL WH ME 2PK
• 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 ; 6166988880
• MDR Report Key: 10280418
• MDR Text Key: 199698458
• Report Number: 1825660-2020-00784
• Device Sequence Number: 1
• Product Code: EFW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MNTB ORB BRIL WH ME 2PK
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/17/2020
• Date Manufacturer Received: 06/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1