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

Model Number 8137009217

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 18-nov-2014 from a female consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach johnson and johnson floss, mint waxed (route-dental; lot number 2983d; frequency and expiration date unspecified) for oral hygiene.After an unspecified duration, when she was dispensing the floss for the first time, the intact metal cutter broke off completely and she was unable to use it.This report had no adverse event.The action taken with the device was unknown.This report was considered a reportable malfunction in the united states.

Manufacturer Narrative

The date of this submission is 03-dec-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is 15-jan-2015.This closes out this report unless other additional significant information is received.

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 reach johnson and johnson floss, mint waxed (route-dental; lot number 2983d; frequency and expiration date unspecified) for oral hygiene.After an unspecified duration, when she was dispensing the floss for the first time, the intact metal cutter broke off completely and she was unable to use it.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 02-jan-2015.The returned sample received on 10-dec-2014 with printed lot number 2983d was visually evaluated on 23-dec-2014.The insert was broken on the edge where the cutter was hooked.The field sample does not meet specification.A review of the data revealed no trend for the lot number.The retained sample was visually evaluated and it did not present any defects, all product components presented in good condition.The device history records were reviewed and no issues, defects or investigations were created related to insert breakage defect.Manufacturing related issues were reviewed and no issues were found, associated with the lot number and product reported for insert breakage defect.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, MINT 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: 4292808
• MDR Text Key: 18064473
• Report Number: 8041101-2014-00050
• 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: 11/18/2014

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: 8137009217
• Device Lot Number: 2983D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 01/02/2014
• Initial Date FDA Received: 12/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: NI
• Patient Sequence Number: 1