MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON REACH CLEAN BURST CINNAMON DENTAL FLOSS

Model Number 8137009219

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 03-nov-2017.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 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 reach clean burst cinnamon dental floss (medium size), dentally, once for oral care (lot number 1087d and expiration date unspecified).At second or third use of device, the metal cutter broke off and it was broken where the floss was supposed to be cut and when consumer opened the lid to see the metal cutter it fell off and was broken.The consumer also mentioned that the floss broke off and the metal cutter snapped off.The consumer described that the metal cutter was separated and was on downside.The consumer also mentioned that the plastic insert also broke and was snapped.This report had no adverse event and the action taken with the device was unknown.A review of complaint data revealed no unfavourable 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/or retain sample reviewed.Based on the information available, the device was used for intended treatment.The analysis for the product and complaint category will be managed through monthly trending process.The complaint investigation was closed with disposition of undetermined.Complaint trends will continue to be monitored.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Corrected data: udi #: (b)(4).Device evaluation: product was returned for investigation for broken cutter.Upon visual evaluation of the returned device, it was noted that the sample was received with insert breakage, however the cutter was attached in the plastic.At this time, no conclusion is able to be drawn about the cause of the metal cutter separation as no additional information is available regarding the use of the device.If information is obtained that was not available for the follow-up #1 medwatch, an additional follow-up medwatch will be filed as appropriate.

• Brand Name: JOHNSON AND JOHNSON REACH CLEAN BURST CINNAMON DENTAL FLOSS
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial de itabo; carretera sánchez km. 18.5; haina 91000 ; DR 91000
• Manufacturer Contact: linda plews ; 199 grandview rd; 199 grandview road; skillman, NJ 08558 ; 2152737120
• MDR Report Key: 6998734
• MDR Text Key: 92048992
• Report Number: 8041101-2017-00033
• 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: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009219
• Device Lot Number: 1087D
• Other Device ID Number: (01)8137009219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1