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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS FLOSS / TAPE AP; DENTAL FLOSS

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JOHNSON & JOHNSON CONSUMER PRODUCTS FLOSS / TAPE AP; DENTAL FLOSS Back to Search Results
Model Number 0041802738
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This foreign report is being submitted on 11-jan-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional significant information is received.
 
Event Description
This spontaneous report was received on 25-dec-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number, expiration date, frequency and indication unspecified).After an unspecified duration, the consumer noticed that a cutter came off from the container when the device was used.This report had no adverse event and the action taken with the device was unknown.The lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.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.This report was considered a reportable malfunction in the united states of america.
 
Manufacturer Narrative
This foreign report is being submitted on 01-feb-2016 for a device product that is considered same/similar to a us marketed device (reach j&j floss waxed 55yd).This closes out this report unless additional significant information is received.
 
Event Description
This spontaneous report was received on 25-dec-2015 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer started using reach floss waxed 55yd (route dental, lot number, expiration date, frequency and indication unspecified).After an unspecified duration, the consumer noticed that a cutter came off from the container when the device was used.This report had no adverse event and the action taken with the device was unknown.The lot number was not reported therefore a batch record review or retain analysis could not be requested or a lot trend analysis performed.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.This report was considered a reportable malfunction in the united states of america.Additional information was received on 11-jan-2016.Based on quality investigation, the device was used for intended treatment.This report remains a reportable malfunction case in the united states of america.
 
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Brand Name
FLOSS / TAPE AP
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
julie thomas
johnson & johnson consumer inc
199 grandview road
skillman, NJ 08558
9082557895
MDR Report Key5356535
MDR Text Key35493898
Report Number8041101-2016-00002
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/25/2015
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 Number0041802738
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 12/25/2015
Initial Date FDA Received01/11/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/01/2016
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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