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

Model Number PKFL MM II 150CT

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 09/12/2021

Event Type  Injury  

Event 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
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): RANIR LLC; 4701 east paris ave se; grand rapids MI 49512 5353
• MDR Report Key: 12579467
• MDR Text Key: 274909815
• Report Number: 1825660-2021-01013
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 00651080186513
• UDI-Public: 651080186513
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/12/2021
• Initial Date FDA Received: 10/05/2021
• 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