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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER REPLACEMENT HEADS
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JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER REPLACEMENT HEADS Back to Search Results
Model Number 1254744019
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The date of this submission is 21-nov-2016.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 07-nov-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 listerine ultraclean access dental flosser replacement heads, (flavored) dentally for oral hygiene (lot number 1896d, frequency and expiration date unspecified).The consumer mentioned to have changed disposable head with every flossing.After an unspecified duration, in (b)(6) 2016 on the weekend prior to reporting, while flossing, the piece of u-shaped plastic came off from disposable head of the flosser in the customers mouth during use.The consumer stated that one replacement head was already broken with a loose piece of plastic in the package.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 26-dec-2016.This report was re-assessed to be not reportable malfunction based on follow-up information received on 08-dec-2016.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 07-nov-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 listerine ultraclean access dental flosser replacement heads, (flavored) dentally for oral hygiene (lot number 1896d, frequency and expiration date unspecified).The consumer mentioned to have changed disposable head with every flossing.After an unspecified duration, in (b)(6) 2016 on the weekend prior to reporting, while flossing, the piece of u-shaped plastic came off from disposable head of the flosser in the customers mouth during use.The consumer stated that one replacement head was already broken with a loose piece of plastic in the package.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 08-dec-2016 on 08-dec-2016, eight of twenty eight heads of device was received.On 15-dec-2016, they were visually inspected according to product specifications and test method by appearance and lot number was identified.Six were received unused and meet specifications for appearance.The flosser heads were not broken nor were pieces of plastic were broken loose.Visual inspection was performed on the retain samples and all results met specification.Field samples indicated one unused flosser head with an empty cavity which means the flavor is not present on the u-shaped plastic head, and the other one was received used with detached flavor.A review of complaint data revealed no unfavourable trends for the reported lot number.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.This report had no adverse event.This report reassessed as a not reportable malfunction in the united states of america.
 
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Brand Name
LISTERINE ULTRACLEAN ACCESS DENTAL FLOSSER REPLACEMENT HEADS
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 Key6116155
MDR Text Key60420546
Report Number8041101-2016-00034
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/07/2016
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 Number1254744019
Device Lot Number1896D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2016
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 11/07/2016
Initial Date FDA Received11/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/26/2016
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Removal/Correction NumberNI
Patient Sequence Number1
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