MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT; FLOSS, DENTAL

Model Number 12547440195

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided for reporting.Upc: (b)(4), lot number : ni, exp date: na, udi: (b)(4).Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with listerine ultraclean access flosser replace heads.Consumer states that the consumer had a few flosser heads that came off.There was no adverse event associated with this event.

• Brand Name: LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview road; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10468581
• MDR Text Key: 231460448
• Report Number: 8041101-2020-00016
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440195
• UDI-Public: (01)12547440195(10)NI
• 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: 08/07/2020

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 Operator: Lay User/Patient
• Device Model Number: 12547440195
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1