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

Model Number 8137009217

Device Problem Break (1069)

Patient Problem Radiation Underdose (2166)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 20-feb-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 10-feb-2017 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 (lot number 2456d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the device metal cutter broke off.The consumer had to open the lid to see the metal cutter.The consumer did not know whether the device broke when it was purchased or when the consumer dropped it.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 of america.

Manufacturer Narrative

This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2017 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 (lot number 2456d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that the device metal cutter broke off.The consumer had to open the lid to see the metal cutter.The consumer did not know whether the device broke when it was purchased or when the consumer dropped it.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 of america.Additional information was received on 28-mar-2017.A review of complaint data revealed no unfavorable trends for the reported lot number.Device history records were reviewed and no deviations or non-conformances were noted.Visual inspection was performed on the retain samples and all results met specification.Product met specification as documented in the records and or retained sample reviewed.The field sample photos showed insert breakage and had been verified.In addition, based on the investigation results, there was evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of confirmed.A review of the data associated with the defect plastic insert assembly with cutter portions breaks during use for medium size was performed and no unfavorable trends was identified.Complaint trends will continue to be monitored.This report had no adverse event.This report remains as reportable malfunction with no adverse event in the united states of america.

• Brand Name: JOHNSON AND 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: 6342669
• MDR Text Key: 67939663
• Report Number: 8041101-2017-00008
• 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: 02/10/2017

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 Model Number: 8137009217
• Device Lot Number: 2456D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1