MAUDE Adverse Event Report: PLACKERS PKFL MM II 150CT; FLOSS, DENTAL

Model Number	PKFL MM II 150CT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer stated: last night i was flossing my teeth before bed and my crown on my upper right hand side came flying out.Unfortunately i have to wait until my dentist office opens for them to access the damage.Consumer email response: top right hand side molar.Crown popped off as i was flossing.Also, i thought i should mention that i just had my routine 6 month dental exam recently and the dentist found nothing wrong with my crown.

• Brand Name: PLACKERS PKFL MM II 150CT
• Common Device Name: FLOSS, DENTAL
• MDR Report Key: 12579467
• Report Number: 1825660-2021-01013
• Device Sequence Number: 3787945
• Product Code: JES
• UDI-Device Identifier: 00651080186513
• UDI-Public: 651080186513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: PKFL MM II 150CT
• Device Lot Number: 0206M
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/12/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2021
• Initial Report FDA Received Date: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1