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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
Lot Number 3276D
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The date of this submission is 11-aug-2017.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 28-jul-2017 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 dentally, for general oral hygiene (lot number 3276d, frequency and expiration date unspecified).After an unspecified duration, when the consumer tried to take out the device from the package, the little metal cutter broke off completely from the plastic insert inside the container during use.The consumer tried to put it together into the container but it still did not work.The consumer had to open lid to see cutter.It was reported that plastic insert was broken while opening.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 01-sep-2017.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 28-jul-2017 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 dentally, for general oral hygiene (lot number 3276d, frequency and expiration date unspecified).After an unspecified duration, when the consumer went to take out the device from the package, the little metal cutter broke off completely from the plastic insert inside the container during use.The consumer tried to put it together into the container but it still did not work.The consumer had to open lid to see cutter.It was reported that plastic insert was broken while opening.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 25-aug-2017.A review of complaint data revealed no unfavorable trends for the reported lot number.Device history records were reviewed and no deviations or non conformance were noted.Visual inspection was performed on the retain samples and all results met specification.Product met specification as documented in the records and retain sample review.The analysis for the 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 reportable malfunction case in the united states of america.
 
Manufacturer Narrative
The date of this submission is 29-sep-2017.This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 28-jul-2017 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 dentally, for general oral hygiene (lot number 3276d, frequency and expiration date unspecified).After an unspecified duration, when the consumer went to take out the device from the package, the little metal cutter broke off completely from the plastic insert inside the container during use.The consumer tried to put it together into the container but it still did not work.The consumer had to open lid to see cutter.It was reported that plastic insert was broken while opening.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 25-aug-2017.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 retain samples and all results met specification.Product met specification as documented in the records and retain sample review.The analysis for the 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 reportable malfunction case in the united states of america.Additional information was received on 19-sep-2017.The samples of reach mint waxed 55yd was received on 06-sep-2017 and was visually examined on (b)(6) 2017, according to product specification and test method by appearance.The sample was received used.The sample does not meet specifications due to the product was received with insert breakage.Lot number 3276d was identified.As the field sample was verified, this defect will be monitored in monthly trends.This report remains 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
nilay gami
johnson & johnson consumer inc
199 grandview road
skillman, NJ 08558
6094559402
MDR Report Key6787380
MDR Text Key83695181
Report Number8041101-2017-00026
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,Followup
Report Date 07/28/2017
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 Lot Number3276D
Other Device ID NumberUDI # 381370092179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2017
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 07/28/2017
Initial Date FDA Received08/11/2017
Supplement Dates Manufacturer Received08/25/2017
09/19/2017
Supplement Dates FDA Received09/01/2017
09/29/2017
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Removal/Correction NumberNI
Patient Sequence Number1
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