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

Model Number 8137009229

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The date of this submission is 27-dec-2016.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 13-dec-2016 from a female consumer (age unspecified) reporting on self from the (b)(6).On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally (lot number 2561d, frequency, indication and expiration date unspecified).After an unspecified duration, while dispensing, the consumer noticed the metal part of device fell off due to unclear reasons.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 08-feb-2017.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 13-dec-2016 from a female consumer (age unspecified) reporting on self from the (b)(6).On an unspecified date, the consumer started using johnson and johnson floss, mint waxed dentally (lot number 2561d, frequency, indication and expiration date unspecified).After an unspecified duration, while dispensing, the consumer noticed the metal part of device fell off due to unclear reasons.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 10-jan-2017.On 27-dec-2016, field sample of reach dental floss waxed mint was received which was visually examined on (b)(6) 2017.The product code was updated from johnson and johnson floss mint waxed to johnson and johnson floss mint waxed 100yd.Device history records were reviewed and no deviations or non-conformances were noted.Visual inspection was performed on the retained samples and all results met specification.The field sample did not meet specifications as it was received with insert breakage.A review of complaint data revealed no unfavorable trends for the reported lot number.The analysis for this product and complaint category will be managed through monthly trending process.Product met specification for retain sample review.Based on the information available, the device was used for intended treatment.The complaint investigation was closed with a disposition of confirmed.The complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states of america.

• Brand Name: JOHNSON & JOHNSON FLOSS, MINT WAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal
• 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: 6204622
• MDR Text Key: 63373845
• Report Number: 8041101-2016-00040
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/13/2016

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 Model Number: 8137009229
• Device Lot Number: 2561D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1