MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU LISTERINE ULTRACLEAN ACCESS FLOSSER STARTER KIT; DENTAL FLOSS

Model Number 12547440188

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Upc: (b)(4), lot number:16919d, udi: (b)(4).The device has been returned to the manufacturer.The flosser heads was 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.A review of the device history records has been requested.(b)(4).If information is obtained that was not available for the initial medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported an event with listerine ultraclean access flosser replace heads mint.The consumer stated that the whole thing, replacement head, separated from the handle and stuck in consumer mouth.There was no adverse event related to this event.

Manufacturer Narrative

Johnson & johnson consumer, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which johnson & johnson consumer, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, johnson & johnson consumer, inc.Or its employees that the report constitutes an admission that the device, johnson & johnson consumer, inc., or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Corrected data: upc; udi.D10: upon investigation it was noted by manufacturing site that lot number was not for replacement heads which was originally reported in initial emdr.As such, the device, listerine ultraclean access flosser starter kit , has not been returned to the manufacturer and sample received updated was updated to "no".H3: device not evaluated by manufacturing site.H4, h6: 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 june 18,2019.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 STARTER KIT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; 199 grandview rd; skillman NJ 08558
• MDR Report Key: 9602465
• MDR Text Key: 220827839
• Report Number: 8041101-2020-00002
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 12547440195
• UDI-Public: (01)12547440195(10)16919D
• 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: 02/03/2020

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: 12547440188
• Device Lot Number: 16919D
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/03/2020
• Event Location: Other
• Initial Date Manufacturer Received: 12/24/2019
• Initial Date FDA Received: 01/17/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/06/2020
• Patient Sequence Number: 1