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

Model Number 8137009213

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 05-nov-2014 from a consumer (age and gender unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach johnson and johnson floss, waxed (route- dental, lot number 1413d, frequency and expiration date unspecified) for oral health.While using the floss for the first time, the consumer pulled the string and noticed that the metal cutter including the inner parts or plastic assembly came off the container entirely.This report had no adverse event and 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 19-nov-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is (b)(6) 2014.This closes out this report unless other additional significant information is received.

Event Description

Additional information was received on (b)(6) 2014.The returned sample received on (b)(6) 2014 was visually examined with a printed lot number 1413d.The insert is broken on the edge where the cutter is hooked.According to the visual evaluation the field sample does not meet specification a review of the data associated with the complaint category insert breakage defect for medium insert size revealed no trend for the lot number.The retain sample was visually evaluated and does not present any defect.All product components (cutter, insert, bobbin and dispenser) present good conditions.The device history records were reviewed and no issue, defect or investigation was created related to insert breakage defect.The manufacturing related issues were reviewed, and there was no issue found or associated to the lot number and product reported for insert breakage defect.The device was used as intended for treatment.The complaint investigation was closed with a disposition of confirmed since the field sample was received with broken insert.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.

• Brand Name: JOHNSON & JOHNSON FLOSS, WAXED
• 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: 4260802
• MDR Text Key: 5050819
• Report Number: 8041101-2014-00048
• 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: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009213
• Device Lot Number: 1413D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: NI
• Patient Sequence Number: 1