MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS JOHNSON AND JOHNSON REACH CLEAN BURST CINNAMON DENTAL FLOSS

Model Number 8137009219

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

This spontaneous report was received on 30-jun-2015 from a reporter reporting on her husband (age unspecified) from the united states.On an unspecified date, the consumer opened johnson and johnson reach clean burst cinnamon dental floss (route-dental, lot number 1365d; frequency and expiration date unspecified) for an unknown indication.Upon opening the device, the plastic insert popped out, the bobbin came out and he noticed that the metal cutter was not intact.The reporter tried to get the spool back into the plastic but could not reinsert it and was not able to dispense the floss properly.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction case in the united states.

Manufacturer Narrative

The date of this submission is 10-jul-2015.This closes out this report unless other additional significant information is received.

Manufacturer Narrative

This closes out this report unless other additional significant information is received.

Event Description

This spontaneous report was received on (b)(6)-2015 from a reporter reporting on her husband (age unspecified) from the united states.On an unspecified date, the consumer opened johnson and johnson reach clean burst cinnamon dental floss (route-dental, lot number 1365d; frequency and expiration date unspecified) for an unknown indication.Upon opening the device, the plastic insert popped out, the bobbin came out and he noticed that the metal cutter was not intact.The reporter tried to get the spool back into the plastic but could not reinsert it and was not able to dispense the floss properly.The action taken with the device was unknown.This report had no adverse event.This report was considered a reportable malfunction case in the united states.Additional information was received on 09-jul-2015.The product name was updated from reach johnson and johnson floss clean burst cinnamon usa refcbcus to reach johnson and johnson floss clean burst cinna 55yd usa (b)(4).One reach johnson and johnson floss clean burst cinna 55yd usa 200921910 was received, opened and used on 09-jul-2015 and was visually inspected on 15-jul-2015 according to product specification and test method.The lot number was identified as 1365d.The plastic insert and metal cutter were intact.There was no evidence of separation of the cutter from plastic portion and any broken components.The sample met specifications for appearance and dispensed properly.Based on the returned sample investigation the report was re-assessed as a non-reportable product quality complaint in the united states.

• Brand Name: JOHNSON AND JOHNSON REACH CLEAN BURST CINNAMON DENTAL FLOSS
• 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: julie thomas ; johnson & johnson consumer inc; 199 grandview road; skillman, NJ 08558 ; 9082557895
• MDR Report Key: 4904621
• MDR Text Key: 16962036
• Report Number: 8041101-2015-00025
• 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: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8137009219
• Device Lot Number: 1365D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Removal/Correction Number: NI
• Patient Sequence Number: 1