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  

Event Description

This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender 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 1014d, frequency and expiration date unspecified) to floss teeth.After an unspecified duration, the consumer noticed that the metal cutter and plastic clip assembly were completely loose.When the consumer tried to dispense the floss for the first time, the metal cutter head was pulled out with the floss without completely breaking and the plastic insert and clip assembly popped out.The consumer attempted to reinsert the plastic insert back into the container but it did not dispense properly.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 11-jun-2015.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

This spontaneous report was received on 28-may-2015 from a consumer (age and gender 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 1014d, frequency and expiration date unspecified) to floss teeth.After an unspecified duration, the consumer noticed that the metal cutter and plastic clip assembly were completely loose.When the consumer tried to dispense the floss for the first time, the metal cutter head was pulled out with the floss without completely breaking and the plastic insert and clip assembly popped out.The consumer attempted to reinsert the plastic insert back into the container but it did not dispense properly.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.Additional information was received on 11-jul-2015.The device was used for oral hygiene.The sample was not received.A review of the lot trending data revealed no trend for the reported lot number.The retained sample was evaluated and it met specifications for appearance.The device history review and manufacturing related issues demonstrated adequate controls and the product met specifications.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.

• 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 NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: julie thomas ; 199 grandview road; ni; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 4837294
• MDR Text Key: 5912782
• Report Number: 8041101-2015-00022
• 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: 05/28/2015

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: 1014D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/11/2015
• Initial Date FDA Received: 06/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Removal/Correction Number: NI
• Patient Sequence Number: 1