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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE TOTAL CARE DENTAL FLOSS

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JOHNSON & JOHNSON CONSUMER PRODUCTS LISTERINE TOTAL CARE DENTAL FLOSS Back to Search Results
Model Number 6260096268
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
This spontaneous report was received on 13-jul-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).The medical history included sleep disorder.The concomitant medications included unspecified sleeping pills for sleep disorder.On an unspecified date, the consumer started using listerine total care dental floss, for oral hygiene (route dental, lot number 1654d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the top of the floss package, which cuts the floss, broke off from the floss container.The consumer opened a lid to see the metal cutter and noticed the plastic insert was broken.The consumer also noticed that there was no piece of the floss available outside of the package to pull out and cut, so the consumer removed the cutter.Every time the consumer used the floss, the consumer had to pull the floss out and use a scissors to cut the floss.The consumer tried using second floss and noticed the same problem.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states.
 
Manufacturer Narrative
This foreign report is being submitted on 05-aug-2015 for a device that is considered same/similar to a us marketed device (listerine ultraclean mint floss).This is an initial submission for the first product in this case.The manufacturer report number for the second product in this case is 8041101-2015-00027.This closes out this report unless additional follow up information is received.
 
Manufacturer Narrative
This foreign report is being submitted on 22-sep-2015 for a device that is considered same/similar to a us marketed device (listerine ultraclean mint floss).This is a follow up submission for the first product in this case.The manufacturer report number for this submission is 8041101-2015-00026.The manufacturer report number for the second product in this case is 8041101-2015-00027.This closes out this report unless additional follow up information is received.
 
Event Description
This spontaneous report was received on 13-jul-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).The medical history included sleep disorder.The concomitant medications included unspecified sleeping pills for sleep disorder.On an unspecified date, the consumer started using listerine total care dental floss, for oral hygiene (route dental, lot number 1654d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed the top of the floss package, which cuts the floss, broke off from the floss container.The consumer opened a lid to see the metal cutter and noticed the plastic insert was broken.The consumer also noticed that there was no piece of the floss available outside of the package to pull out and cut, so the consumer removed the cutter.Every time the consumer used the floss, the consumer had to pull the floss out and use a scissors to cut the floss.The consumer tried using second floss and noticed the same problem.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.Additional information was received 27-aug-2015.A review of the data revealed no prior complaints for the reported lot number.A device history record review was conducted, no non conformance or deviations were noted.A retain sample evaluation was conducted, visual inspection results were within specification.The analysis of product and complaint category will be managed through a monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.The case remains reportable malfunction in the united states of america.
 
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Brand Name
LISTERINE TOTAL CARE DENTAL FLOSS
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
johnson & johnson consumer inc
199 grandview road
skillman, NJ 08558
9082557895
MDR Report Key4973071
MDR Text Key17695081
Report Number8041101-2015-00026
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,consumer,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 07/13/2015
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 Number6260096268
Device Lot Number1654D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 07/13/2015
Initial Date FDA Received08/05/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Removal/Correction NumberNI
Patient Sequence Number1
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