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

Model Number 8137009215

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on (b)(6) 2014 from a female consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using johnson and johnson floss unwaxed (route-dental, lot number and expiration date unspecified) for general oral hygiene.After an unspecified duration, while trying to pull and cut the floss, the metal cutter did not cut and it broke off completely from the plastic insert inside the container.The consumer stated that whole thing came apart because the metal cutter was broken off.Consumer tried to put it back together but it kept coming apart and had to use scissors to cut the floss.This report had no adverse event.The action taken with the device was unknown.This report was considered a reportable malfunction case in the united states.

Manufacturer Narrative

The date of this submission is (b)(4) 2015.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is 27-jan-2015.This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on 26-dec-2014 from a female consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using johnson and johnson floss unwaxed (route-dental, lot number and expiration date unspecified) for general oral hygiene.After an unspecified duration, while trying to pull and cut the floss, the metal cutter did not cut and it broke off completely from the plastic insert inside the container.The consumer stated that whole thing came apart because the metal cutter was broken off.Consumer tried to put it back together but it kept coming apart and had to use scissors to cut the floss.This report had no adverse event.The action taken with the device was unknown.This report was considered a reportable malfunction case in the united states.Additional information was received on 17-jan-2015.The sample has not been received for evaluation.Manufacturing related issues were reviewed and no issues were found associated with the loose cutter defect for the product reported.A lot number was not reported, therefore no further investigation can be performed.The complaint investigation was closed with a disposition of undetermined.The device was used for oral hygiene.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.

• Brand Name: JOHNSON & JOHNSON FLOSS, UNWAXED
• Type of Device: DENTAL FLOSS
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; san cristobal NI ; DR NI
• Manufacturer (Section G): JOHNSON & JOHNSON CONSUMER PRODUCTS; parque industrial itabo haina; ni; san cristobal NI ; DR NI
• Manufacturer Contact: amal yamany ; 199 grandview road; ni; skillman, NJ 08558 ; 9089043455
• MDR Report Key: 4416032
• MDR Text Key: 5167627
• Report Number: 8041101-2015-00001
• 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: 12/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009215
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Removal/Correction Number: NI
• Patient Sequence Number: 1