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

Model Number 381370092179

Device Problem Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of birth and weight were not provided for reporting.(b)(4).A review of the device history records 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 initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the consumer that metal cutter had fallen out with the floss on it.Additionally, consumer stated that "plastic wasn't broken." and "it popped out.Came out with floss on it." 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.Corrected data: expiration date, udi: (b)(4).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 february 01, 2017.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 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: 7362467
• MDR Text Key: 103440295
• Report Number: 8041101-2018-00009
• Device Sequence Number: 1
• Product Code: JES
• 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,Followup
• Report Date: 03/29/2018

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 Expiration Date: 01/31/2022
• Device Model Number: 381370092179
• Device Lot Number: 0327D
• Other Device ID Number: (01)381370092179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1