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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient ethnicity and race was not provided for reporting.This report is for unknown reach j&j floss waxed mint.Upc#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A female consumer reported an event with reach j&j floss waxed mint unspecified.When flossing her teeth with the product, the floss shredded and stuck between the consumer¿s molars.After repeated attempts, the consumer was unable to remove the floss.The consumer needed an office visit to the dentist to have the floss removed from between her teeth.The consumer¿s symptoms have resolved.

• Brand Name: REACH J&J FLOSS WAXED MINT
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558
• 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: laurie rauco ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152734905
• MDR Report Key: 9447343
• MDR Text Key: 185532104
• Report Number: 8041101-2019-00057
• 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
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 78