MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER REPLACEMENT HEADS

Model Number 12547440195

Device Problems Break (1069); 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.Date of birth and weight were not provided for reporting.(b)(4).Device was not returned.Pending evaluation of manufacturing review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer alleged the replacement flosser head separated from the handle inside consumer's mouth.Consumer also alleged during flossing, the floss broke and the u-shaped plastic head broke while still attached to the handle.

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.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 ULTRACLEAN ACCESS DENTAL FLOSSER REPLACEMENT HEADS
• 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 INDU; carretera sánchez km. 18.5; ni; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; ni; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7183723
• MDR Text Key: 97759212
• Report Number: 8041101-2018-00001
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2021
• Device Model Number: 12547440195
• Device Lot Number: 2006D
• Other Device ID Number: (01)12547440195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1