MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC LISTERINE ULTRACLEAN ACCESS FLOSSER; DENTAL FLOSS

Model Number 12547440188

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The lot number was not reported.The udi# is (b)(4).The lot number and expiration date were not reported.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.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 the head that holds the actual flosser broke in half.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Product was returned for investigation.Lot number was available for reporting.The (neck) portion was noted broken on the returned flosser handle.Sample was classified as biological waste and are not inspected or tested.Additionally the reported complaint no longer meets the threshold of being a reportable malfunction.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
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview 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: 7992276
• MDR Text Key: 125794092
• Report Number: 8041101-2018-00028
• 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: 10/25/2018

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: 12547440188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Event Location: Other
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1