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

Lot Number 0447D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2017 from a male consumer (age unspecified) reporting on self from 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 0447d, frequency and expiration date unspecified).After an unspecified duration, the consumer noticed that, the plastic insert and the metal cutter broke off while pulling the floss.The consumer stated to have opened a lid to see the metal cutter and noticed that the plastic insert was broken and while pulling the floss the metal cutter broke.It was also reported that when the consumer opened the container for the first time the metal cutter was intact but the plastic piece was cracked.The consumer tried to put it back but it did not go back into place and when tried to pull out again the plastic piece came out again.This report had no adverse event and the action taken with the device was unknown.On 17-apr-2017 the sample of reach dental floss mint waxed 55yd was received.On 28-apr-2017 the returned sample was visually examined.Also, the sample was compared against the visual standard of the product.Lot number 0447d was identified.The sample did not meet specifications as it was received with insert breakage, however, the cutter was attached in the plastic.A review of complaint data revealed no unfavourable 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.In addition, based on the field sample results, there was evidence that a device malfunction occurred.Based on the information available, the device was used for intended treatment.The analysis of product and complaint category trend 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 was considered 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: 6656098
• MDR Text Key: 78158928
• Report Number: 8041101-2017-00018
• 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
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0447D
• Other Device ID Number: UDI # 381370092179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Event Location: Other
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1