MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON & JOHNSON FLOSS, MINT WAXED 55YD USA; DENTAL FLOSS

Model Number 8137009217

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 18-nov-2014 from a male consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach johnson and johnson floss, mint waxed (route: dental, lot number 2020d, frequency and expiration date unspecified), to floss teeth.After an unspecified duration, while using the floss dispenser for the first time, the consumer stated that the whole plastic dispenser cracked in half and broke while dispensing the floss.The metal cutter and plastic piece that held the metal cutter where it was attached also broke off and came out of the container entirely.The consumer mentioned that he tried to fix the device and was able to put it back together to get it to work.This report had no adverse event and the action taken with the device was unknown.This report was considered a reportable malfunction in the united states.

Manufacturer Narrative

The date of this submission is 03-dec-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is (b)(6) 2015.This closes out this report unless other additional significant information is received.

Event Description

Additional information was received on (b)(6) 2014.The device name was updated from reach johnson and johnson floss waxed mint usa to reach johnson and johnson floss waxed mint 55yd usa.A review of the data revealed no trend for the reported lot number.Visual inspection of the retained sample could not be performed as there is only one retain sample available and a minimum of one sample is required to be retained for each lot to verify the package.The device history records were reviewed and no issue, defect or investigation was created related to insert breakage defect.The complaint sample has not been received for evaluation.The complaint investigation was closed with a disposition of undetermined.The device was used for treatment.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.This report remains a reportable malfunction case in the united states.

• Brand Name: JOHNSON & JOHNSON FLOSS, MINT WAXED 55YD USA
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: amal yamany ; 199 grandview road; ni; skillman, NJ 08558 ; 9089043455
• MDR Report Key: 4292814
• MDR Text Key: 21530420
• Report Number: 8041101-2014-00051
• 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: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• 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: 2020D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Removal/Correction Number: NI
• Patient Sequence Number: 1