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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE GENTLE GUM CARE MINT FLOSS; DENTAL FLOSS
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JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE GENTLE GUM CARE MINT FLOSS; DENTAL FLOSS Back to Search Results
Model Number 1254744015
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The date of this submission is 10-nov-2016.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 19-oct-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 gentle gum care mint floss, dentally for an unknown indication (lot number 1605d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the floss shredded while using and the metal thing that cuts the floss fell off.It was stated that the device was blue with white and it was only white before.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 22-dec-2016.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 19-oct-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 gentle gum care mint floss, dentally for an unknown indication (lot number 1605d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the floss shredded while using and the metal thing that cuts the floss fell off.It was stated that the device was blue with white and it was only white before.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 02-dec-2016.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 retained samples and all results met specification.The analysis for this product and complaint category will be managed through monthly trending process.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains as reportable malfunction case in the united states of america.
 
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Brand Name
LISTERINE GENTLE GUM CARE 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 Key6091842
MDR Text Key59838558
Report Number8041101-2016-00032
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 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1254744015
Device Lot Number1605D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Date Manufacturer Received12/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Removal/Correction NumberNI
Patient Sequence Number1
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