MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU 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 age, weight and ethicinity were not provided for reporting.Udi: (b)(4), upc: 12547440195, lot number:28419d.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.A review of the device history records has been requested.This is 2 of 4 med-watches being submitted as four devices were involved in this event.See medwatches 8041101-2020-00009; 8041101-2020-00011; 8041101-2020-00012.The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported four listerine ultraclean access flosser replace heads separated from the handle when using it inside the mouth.There were no adverse event reported with this event.This is 2 of 4 med-watches being submitted as four devices were involved in this event.See medwatches 8041101-2020-00009; 8041101-2020-00011; 8041101-2020-00012.The same patient is represented in each medwatch.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.H4, h6: device history records review was completed.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition and product was manufactured per specification.The product was manufactured on november 10, 2019.This is 2 of 4 med-watches being submitted as four devices were involved in this event.See medwatches 8041101-2020-00009; 8041101-2020-00010; 8041101-2020-00011; 8041101-2020-00012.The same patient is represented in each medwatch.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT
• Type of Device: FLOSS, DENTAL
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• MDR Report Key: 10011781
• MDR Text Key: 226997780
• Report Number: 8041101-2020-00010
• Device Sequence Number: 1
• Product Code: JES
• 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,Followup
• Report Date: 05/17/2020

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
• Device Lot Number: 28419D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 05/17/2020
• Supplement Dates FDA Received: 05/21/2020
• Patient Sequence Number: 1