MAUDE Adverse Event Report: RANIR, A PERRIGO COMPANY / RANIR LLC PLACKERS MICRO MINT; FLOSS, DENTAL

Lot Number 1159C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/14/2021

Event Type  malfunction  

Event Description

I used flossers i purchased to clean my teeth and then noticed a foul aftertaste.I am worried they're may have a carcinogen in them.

• Brand Name: PLACKERS MICRO MINT
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR, A PERRIGO COMPANY / RANIR LLC
• MDR Report Key: 12828420
• MDR Text Key: 281007750
• Report Number: MW5105367
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080187510
• UDI-Public: 651080187510
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1159C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2021
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR ; IRON SUPPLEMENT; MULTIVITAMIN
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White