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

Model Number 1254744019USA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient date of birth was not provided for reporting.Lot # is not available and (b)(4), expiration date= ni, lot number = ni.(b)(4).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 a valid 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

Consumer was using the listerine ultraclean flosser when her tooth broke on the left side of her mouth.She went to the dentist and they want to put a crown on the tooth.

• 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 industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; ni; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 7149438
• MDR Text Key: 95898479
• Report Number: 8041101-2017-00037
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 1254744019USA
• Other Device ID Number: (01)012547440195
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 64