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

Lot Number 0977D

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 24-aug-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 15-aug-2017 from a female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, waxed, dentally, (lot number 0977d, frequency, indication and expiration date unspecified).After an unspecified duration, when consumer pulled the floss, metal piece came off.She also mentioned that the metal piece was too small.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 11-oct-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 female consumer (age unspecified) reporting on self from the united states of america.On an unspecified date, the consumer started using johnson and johnson floss, waxed, dentally, (lot number 0977d, frequency, indication and expiration date unspecified).After an unspecified duration, when consumer pulled the floss, metal piece came off.She also mentioned that the metal piece was too small.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 26-sep-2017.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 retain sample reviewed.In addition, based on the investigation results, there was 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 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: 6816339
• MDR Text Key: 83695170
• Report Number: 8041101-2017-00030
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 0977D
• Other Device ID Number: UDI # 381370092131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1