MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC LISTERINE GENTLE GUM CARE FLOSS MINT; DENTAL FLOSS

Model Number 12547440157

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.Age/date of birth, weight and ethnicity/race were not provided for reporting.(b)(4); expiration date: na; lot number: (10)1158d.Return of the device was requested for manufacturer review/investigation, however consumer only returned one device.See medwatch 8041101-2018-00030.Device has not yet been returned to the manufacturer therefore no conclusion can be drawn.Device history records review has been requested.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00030.The same consumer 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 alleges that while dispensing the listerine gentle gum care floss mint 50yd, a piece of the plastic insert with the metal cutter attached broke off.There were no adverse consumer consequences from this event.This is one of two medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00030.The same consumer is represented in each medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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 april 25, 2018.This is two of two follow-up medwatches being submitted as two devices were involved in this event.See medwatch 8041101-2018-00030.The same patient is represented in each medwatch.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: LISTERINE GENTLE GUM CARE FLOSS MINT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grand view 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: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8110937
• MDR Text Key: 129450986
• Report Number: 8041101-2018-00031
• 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: 12/06/2018

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: 12547440157
• Device Lot Number: 1158D
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/06/2018
• Supplement Dates FDA Received: 12/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1