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

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.

• 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 Key: 6787380
• MDR Text Key: 83695181
• Report Number: 8041101-2017-00026
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3276D
• Other Device ID Number: UDI # 381370092179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1