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

Model Number LSFUNSCA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This foreign report is being submitted on (b)(6) 2016 for a device product that is considered same/similar to a us marketed device (listerine dental floss unspecified).This closes out this report unless additional significant information is received.

Event Description

This spontaneous report was received on (b)(6) 2016 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer noticed that the part of listerine dental floss unspecified used to cut the floss was broken (lot number and expiration date unspecified).The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.

Manufacturer Narrative

This foreign report is being submitted on 03-mar-2016 for a device product that is considered same/similar to a us marketed device ((b)(4) dental floss unspecified).This closes out this report unless additional significant information is received.Device not returned.

Event Description

This spontaneous report was received on (b)(6) 2016 from a consumer (age and gender unspecified) reporting on self from (b)(6).On an unspecified date, the consumer noticed that the part of (b)(4) dental floss unspecified used to cut the floss was broken (lot number and expiration date unspecified).The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction in the united states of america.Additional information was received on 17-feb-2016.The analysis of product and complaint category will be managed through a monthly trending process.A valid lot number was not reported and the complaint sample was not returned.The complaint investigation was closed with a disposition of undetermined.Complaint trends will continue to be monitored.This report remains as a reportable malfunction in the united states of america.

• Brand Name: LISTERINE FLOSS PRODUCTS
• 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: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 5388138
• MDR Text Key: 37009450
• Report Number: 8041101-2016-00007
• Device Sequence Number: 1
• Product Code: JES
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LSFUNSCA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Removal/Correction Number: NI
• Patient Sequence Number: 1