MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS DR REACH J&J FLOSS WAXED USA; DENTAL FLOSS

Model Number 381370092131

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).Multiple devices were used in this single event, this is 1 of 2 emdrs being submitted.Device was not returned.Pending evaluation of manufacturing review.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer stated he purchased 2 new packs of reach waxed floss and the metal cutter was separated from the plastic mount on both packages.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Multiple devices were used in this single event, this is follow up 2.2 of 2 emdrs being submitted.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Corrected data: results code was corrected.Multiple devices were used in this single event, this is follow up 2.1 of 2 emdrs being submitted.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.Multiple devices were used in this single event, this is 2 of 2 follow- up emdrs being submitted.If information is obtained that was not available for this follow-up medwatch, an additional follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.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.Multiple devices were used in this single event, this is 1 of 2 follow- up emdrs being submitted.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: REACH J&J FLOSS WAXED USA
• Type of Device: DENTAL FLOSS
• 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: 7120835
• MDR Text Key: 95903510
• Report Number: 8041101-2017-00035
• 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,Followup,Followup,Followup
• Report Date: 12/28/2017

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: 09/29/2020
• Device Model Number: 381370092131
• Device Lot Number: 2745D
• Other Device ID Number: (01)381370092131
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 12/28/2017; 12/28/2017; 01/25/2018; 01/25/2018
• Supplement Dates FDA Received: 01/11/2018; 01/11/2018; 01/26/2018; 01/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1