MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC JOHNSON & JOHNSON FLOSS, MINT WAXED; REACH J&J FLOSS WAXED MINT

Model Number 381370092179

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 information was not provided for reporting.Udi: (b)(4), upc = (b)(4), expiration date= na, lot number = 1498d.A review of the device history records and device evaluation has been requested.Product was returned for investigation for an broken cutter.Upon visual evaluation of the returned device, it was noted that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.Additional evaluation is pending from manufacturing site.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported that on a reach j&j floss waxed mint 55yd usa the metal part came out when she pulled the floss.The consumer returned the device and the consumer returned field sample was noted with metal cutter completely separated from the insert assembly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device, it was confirmed that the metal cutter was completely separated from the insert assembly.It is unknown how the product was being used at the time.At this time, no conclusion is able to be drawn about the cause of the metal cutter separation as no additional information is available regarding the use of the device.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 may 29, 2018.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: JOHNSON & JOHNSON FLOSS, MINT WAXED
• Type of Device: REACH J&J FLOSS WAXED MINT
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS DR PARQUE INDU; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8039686
• MDR Text Key: 127896758
• Report Number: 8041101-2018-00029
• 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: 11/13/2018

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: 381370092179
• Device Lot Number: 1498D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Event Location: Other
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1