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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS

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JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON FLOSS, MINT WAXED; DENTAL FLOSS Back to Search Results
Model Number 8137009217
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The date of this submission is 23-oct-2015.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on (b)(6) -2015 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed (route: dental, lot number 3434d, frequency and expiration date unspecified) for general oral hygiene.After an unspecified duration, the consumer noticed that the metal cutter and attached piece of plastic broke off from the insert while dispensing, during use and while cutting the floss.The consumer had to open the lid to see the metal cutter.The consumer reported that the metal cutter was still intact to the piece of the plastic and it broke away from the insert.The cutter breakage included plastic insert parts.The consumer stated to have experienced this twice.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-nov-2015.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on (b)(6) 2015 from a consumer (age and gender unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed (route: dental, lot number 3434d, frequency and expiration date unspecified) for general oral hygiene.After an unspecified duration, the consumer noticed that the metal cutter and attached piece of plastic broke off from the insert while dispensing, during use and while cutting the floss.The consumer had to open the lid to see the metal cutter.The consumer reported that the metal cutter was still intact to the piece of the plastic and it broke away from the insert.The cutter breakage included plastic insert parts.The consumer stated to have experienced this twice.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 12-nov-2015.A review of the lot trending data revealed no trend for the reported lot number.The field sample was not received.The retained sample was evaluated and met specifications for appearance.The review of the device history review demonstrated the product met specifications.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states of america.
 
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Brand Name
JOHNSON AND JOHNSON FLOSS, MINT WAXED
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 Key5170797
MDR Text Key29033776
Report Number8041101-2015-00034
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 Followup
Report Date 09/29/2015
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 Number8137009217
Device Lot Number3434D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/26/2015
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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