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

Model Number 8137009234

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 10-apr-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 28-mar-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 oral hygiene (lot number 1916d, frequency and expiration date unspecified).After cutting few pieces of the device, the consumer noticed that the metal cutter came loose and it was half attached while reporting.The consumer mentioned that the right side was attached but the left side was hanging loose.The consumer did not have to open the lid to see the metal cutter and mentioned that it was difficult to pull the floss out of the container as it seemed like the yarn was jammed in the container.The consumer mentioned that the plastic insert did not pop out and plastic spool was not broken.The consumer had to gently shake it for few times before using the device and then it dispensed a normal length of floss.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

This report has been reassessed as a non reportable malfunction case in the united states.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 28-mar-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 oral hygiene (lot number 1916d, frequency and expiration date unspecified).After cutting few pieces of the device, the consumer noticed that the metal cutter came loose and it was half attached while reporting.The consumer mentioned that the right side was attached but the left side was hanging loose.The consumer did not have to open the lid to see the metal cutter and mentioned that it was difficult to pull the floss out of the container as it seemed like the yarn was jammed in the container.The consumer mentioned that the plastic insert did not pop out and plastic spool was not broken.The consumer had to gently shake it for few times before using the device and then it dispensed a normal length of floss.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 05-apr-2017.On 05-apr-2017 one reach floss mint waxed 200 yd was received as sample and the returned sample was visually examined according to product specification and test method by appearance on 19-apr-2017.The sample was compared against the visual standard of the product.The product received as field sample does not meet specification as it was received with loose cutter.Lot number 1916d was identified.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 reviewed.The analysis for this product and complaint categories will be managed through monthly trending process.This case was updated from a reportable malfunction to a non reportable malfunction based on the product and category.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report had no adverse event.This report was considered a non-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: 6476371
• MDR Text Key: 72364813
• Report Number: 8041101-2017-00015
• 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
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009234
• Device Lot Number: 1916D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1