MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC DENTOTAPE SLIM WAXED; DENTAL FLOSS

Model Number 3574661145921

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 identifier, age at time of event, sex, weight and ethnicity and race were not provided for reporting.This report is for dentotape slim waxed 50m eu 3574661145921.Device is not distributed in the united states, but is similar to device marketed in the usa reach j&j floss waxed 55yd usa 381370092131.Lot number is not available.(b)(4).Expiration date= na.Lot number = ni.Device is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa reach j&j floss waxed 55yd usa 381370092131.Device evaluation 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

A consumer reported an event with dentotape slim waxed 50m eu.The consumer reported that the metal cutter went loose.It is unknown if the event happened during or prior to using the product.This is all known information at this time about this complaint.There was no adverse event reported.

• Brand Name: DENTOTAPE SLIM WAXED
• 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: 9484410
• MDR Text Key: 203868014
• Report Number: 8041101-2019-00059
• Device Sequence Number: 1
• Product Code: JES
• UDI-Device Identifier: 3574661145921
• UDI-Public: (01)3574661145921
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 11/20/2019

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: 3574661145921
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1