MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN MINT FLOSS; DENTAL FLOSS

Lot Number 3296D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 17-aug-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 03-aug-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 listerine ultraclean mint floss for flossing teeth (route dental, lot number 3296d, frequency, and expiration date unspecified).After an unspecified duration, the consumer noticed that top where the floss was dispensed popped off and came off; the floss got everywhere and the floss was unusable.The consumer reported that metal cutter was not intact.The plastic insert popped-out and while dispensing the floss the metal cutter broke off completely from the plastic insert inside the container which the consumer described as everything broke.The consumer tried to put the plastic insert back into the container however was not able to dispense the floss 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 of america.

Manufacturer Narrative

The date of this submission is (b)(6) 2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 03-aug-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 listerine ultraclean mint floss for flossing teeth (route dental, lot number 3296d, frequency, and expiration date unspecified).After an unspecified duration, the consumer noticed that top where the floss was dispensed popped off and came off; the floss got everywhere and the floss was unusable.The consumer reported that metal cutter was not intact.The plastic insert popped-out and while dispensing the floss the metal cutter broke off completely from the plastic insert inside the container which the consumer described as everything broke.The consumer tried to put the plastic insert back into the container however was not able to dispense the floss 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 of america.Additional information was received on 18-aug-2017.On 18-aug-2017 one returned sample of johnson and johnson listerine ultraclean mint floss 30yd was received opened and used.On 28-aug-2017 sample was visually examined according to product specification johnson and johnson listerine ultraclean mint floss 30yd and test method by appearance , the sample was compared against the visual standard of the product.A review of complaint data by product and subject category revealed no unfavorable trends for the reported lot number.The analysis for this product and complaint category will be managed through monthly trending process.Visual inspection was performed on the retain samples and all results met specification.The product received as field sample did not meet specifications due to the sample was received was disassembled.This report reassessed as non reportable malfunction case in the united states of america.

• Brand Name: LISTERINE ULTRACLEAN MINT FLOSS
• 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: 6799756
• MDR Text Key: 83198649
• Report Number: 8041101-2017-00028
• 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: 08/03/2017

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 Lot Number: 3296D
• Other Device ID Number: UDI # 012547440133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1