MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS

Model Number 8137009217

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 29-nov 2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2016 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss mint waxed, dentally, for general oral hygiene (frequency, lot number and expiration date unspecified).After an unspecified duration, while dispensing the floss, metal cutter broke off completely from the plastic lid during use.The consumer opened a lid to see the metal cutter which was found to be intact.The cutter breakage include only metal cutter not the plastic insert parts.The consumer had thrown out the plastic dispenser and only had the outer packaging available.Lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.The analysis of product and complaint category will be managed through monthly trending process.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.

• Brand Name: JOHNSON & JOHNSON FLOSS, MINT WAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal ; DR
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal ; DR
• Manufacturer Contact: nilay gami ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 6094559402
• MDR Report Key: 6131582
• MDR Text Key: 61036794
• Report Number: 8041101-2016-00035
• 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
• Report Date: 11/21/2016

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: 8137009217
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1