MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH TOTAL CARE DENTAL FLOSS LISTERINE­ FLAVOR

Model Number 8137009396

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Initial information received on 10-nov-2014 was processed with additional information received on 11-nov-2014.This case has been reassessed as reportable malfunction based upon new information received on 11-nov-2014.This spontaneous report was received on 10-nov-2014 from a female consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach total care dental floss listerine flavor (route-dental, lot number 1403d, frequency and expiration date unspecified) for oral hygiene.She reported that the device was not broken or falling apart when first opened and she was able to dispense the floss.After two days, she noticed the floss would not dispense and the container broke when she pulled up the floss.She reported that the plastic piece on the top popped and came off the container entirely and the metal cutter also popped off after an unspecified duration.She stated further that the plastic insert that holds the spool could barely dispense the floss.She also noticed that the spool of floss would not turn; therefore, she took the device apart with tweezers by lifting the plastic piece.She then noticed the spool was sticking and the center piece bulged on one side instead of being flat when she pulled the spool of floss up while the other side was not spooled correctly.This report had no adverse event.Action taken with the device was unknown.The returned sample with the printed lot 1403d received on 21-nov-2014 was visually examined on 26-nov-2014.It was returned disassembled with the plastic insert, purple bobbin and metal cutter loose inside the dispenser case.In addition, the bobbin was in good condition and no winding defect was observed.The returned sample failed to meet specification because the metal cutter was not attached to the plastic insert.This report was considered a reportable malfunction in the united states.

Manufacturer Narrative

The date of this submission is 02-dec-2014.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

The date of this submission is 30-dec-2014.This closes out this report unless other additional significant information is received.

Event Description

Additional information was received on 23-dec-2014.A review of the data revealed no trend for the reported lot number.The retained sample was visually inspected and did not present any defect associated with the loose cutter.The returned sample failed to meet specification but was re-assembled and dispensed properly.The device history records were reviewed and no issue, defect or investigation was created related to loose cutter defect.The manufacturing related issues were reviewed, and there was no issue found or associated to the lot number and product reported for loose cutter defect.The device was used as intended for treatment.The complaint investigation for difficult to open/use/dispense was closed with a disposition of undetermined and the complaint investigation for damaged/defective dispenser/component was closed with a disposition of confirmed.Complaint trends will continue to be monitored.This report remains a reportable malfunction case in the united states.

• Brand Name: REACH TOTAL CARE DENTAL FLOSS LISTERINE­ FLAVOR
• 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: 4288744
• MDR Text Key: 5055498
• Report Number: 8041101-2014-00049
• 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: 11/10/2014

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: 8137009396
• Device Lot Number: 1403D
• 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
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: NI
• Patient Sequence Number: 1