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

Lot Number 3056D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is aug 18, 2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on aug 07, 2017 from a reporter reporting on self (age and gender unspecified) from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed, dentally for oral health (lot number 3056d, frequency and expiration date unspecified).It was reported that the consumer had opened the lid to see metal cutter and it was intact.After an unspecified duration, while cutting the floss for first time the 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 did not work.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 29-sep-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 07-aug-2017 from a reporter reporting on self (age and gender unspecified) from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, mint waxed, dentally for oral health (lot number 3056d, frequency and expiration date unspecified).It was reported that the consumer had opened the lid to see metal cutter and it was intact.After an unspecified duration, while cutting the floss for first time the 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 did not work.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 19-sep-2017.The sample was received on 22-aug-2017 and was visually examined on (b)(6) 2017.The returned sample was visually examined according to product specification and test method by appearance.The sample was compared against the visual standard of the product.One j&j reach floss mint waxed 55yd (b)(4) was received opened and used.Lot number 3056d was identified.The product received as field sample did not meet specifications due to the sample was received with insert breakage.A review of complaint data revealed no unfavorable trends for the reported lot number.Visual inspection was performed on the retain samples and all results met specification.Device history records were reviewed and no deviations or non-conformances were noted.Product met specification as documented in the records and retain sample reviewed.In addition, based on the investigation results, there is evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The analysis for this product and complaint category will be managed through monthly trending process.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains a reportable malfunction 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: 6803118
• MDR Text Key: 82983791
• Report Number: 8041101-2017-00029
• 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: 08/07/2017

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 Number: 3056D
• Other Device ID Number: UDI # 381370092179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1