MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT; DENTAL FLOSS

Model Number 12547440195

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.Patient age, date of birth, weight and ethnicity were not provided for reporting.Upc: (b)(4), lot number:18519d udi: (b)(4), exp date na.The device has been returned to the manufacturer.The flosser heads were received open and used.As per current procedure a field sample evaluation is not required, since returned field sample was classified as biological waste and are not inspected or tested.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 july 4, 2019.If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported a malfunction with listerine mint ultraclean access flosser replace heads.The consumer stated that the replacement head snapped off the handle during use.There was no adverse event related to this event.

• Brand Name: LISTERINE ULTRACLEAN ACCESS FLOSSER REPLACE HEADS MINT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; 199 grandview rd; skillman NJ 08558
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 10091379
• MDR Text Key: 194789741
• Report Number: 8041101-2020-00014
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440195
• UDI-Public: (01)12547440195(10)18519D
• 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
• Report Date: 05/02/2020

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: 12547440195
• Device Lot Number: 18519D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Event Location: Other
• Initial Date Manufacturer Received: 05/02/2020
• Initial Date FDA Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/04/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1