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

Model Number 012547440157

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Partial device is expected to be returned for manufacturer review/investigation but has not yet been received.(b)(4).Device evaluation/investigation could not be completed as product was not returned to manufacturer.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The consumer alleged that when she opened a new container of listerine floss, prior to use, the metal cutter broke and hit her eye; the cutter was completely broken away from the plastic insert.Consumer states that her eye was fine.There is no indication that there was medical intervention or medical treatment for the reported event.

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.Product was manufactured on may, 9, 2017.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 MINT FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7451561
• MDR Text Key: 107081506
• Report Number: 8041101-2018-00013
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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: 012547440157
• Device Lot Number: 1297D
• Other Device ID Number: (01)012547440157
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1