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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER PRODUCTS REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS
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JOHNSON & JOHNSON CONSUMER PRODUCTS REACH TOTAL CARE PLUS WHITENING DENTAL FLOSS Back to Search Results
Model Number 8137109128
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
This spontaneous report was received on 13-may-2015 from a male consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach total care dental floss (route-dental, lot number 1303d, expiration date unspecified) for) for general oral hygiene.After an unspecified duration, he had difficulty dispensing the floss so he pulled it hard.As a result, the metal cutter came off completely and the bobbin came out and separated from the plastic insert which popped out.He mentioned that the plastic insert parts broke off.The consumer attempted to reinsert the plastic insert back into the container but was not able to dispense the floss properly.The returned sample was received on 21-may-2015.Evaluation of the device is anticipated but has not yet begun.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 01-jun-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 male consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach total care dental floss (route-dental, lot number 1303d, expiration date unspecified) for general oral hygiene.After an unspecified duration, he had difficulty dispensing the floss so he pulled it hard.As a result, the metal cutter came off completely and the bobbin came out and separated from the plastic insert which popped out.He mentioned that the plastic insert parts broke off.The consumer attempted to reinsert the plastic insert back into the container but was not able to dispense the floss properly.The returned sample was received on 21-may-2015.Evaluation of the device is anticipated but has not yet begun.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 08-jun-2015.The device name was updated from reach total care dental floss to reach total care plus whitening dental floss.The sample received on 21-may-2015 was visually inspected on 08-jun-2015.One reach total care whitening floss 30yd pc210912800 was received opened and used.The sample did not meet specifications for appearance as the insert was received broken on the edge where the cutter was attached.The broken piece of plastic with the metal cutter was not received.This report remains a reportable malfunction case in the united states.
 
Manufacturer Narrative
This closes out this report unless other additional significant information is received.
 
Event Description
This spontaneous report was received on 13-may-2015 from a male consumer (age unspecified) reporting on self from the united states.On an unspecified date, the consumer started using reach total care dental floss (route-dental, lot number 1303d, expiration date unspecified) for general oral hygiene.After an unspecified duration, he had difficulty dispensing the floss so he pulled it hard.As a result, the metal cutter came off completely and the bobbin came out and separated from the plastic insert which popped out.He mentioned that the plastic insert parts broke off.The consumer attempted to reinsert the plastic insert back into the container but was not able to dispense the floss properly.The returned sample was received on 21-may-2015.Evaluation of the device is anticipated but has not yet begun.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 08-jun-2015.The device name was updated from reach total care dental floss to reach total care plus whitening dental floss.The sample received on 21-may-2015 was visually inspected on 08-jun-2015.One reach total care whitening floss 30yd pc210912800 was received opened and used.The sample did not meet specifications for appearance as the insert was received broken on the edge where the cutter was attached.The broken piece of plastic with the metal cutter was not received.This report remains a reportable malfunction case in the united states.Additional information was received on 28-jun-2015.A review of the data revealed no lot trend for lot number 1303d.A review of non-conformances was performed and no non-conformances related to insert breakage were created.There were no changes to the formula or packaging that could cause the reported defect.Final packaging records, packing records, and incoming records were reviewed and the review indicated the product did not present defects during production inspections and that the appropriate components were used.A retained sample was previously evaluated and met specifications for appearance.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.
 
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Brand Name
REACH TOTAL CARE PLUS WHITENING 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 Key4807886
MDR Text Key5922970
Report Number8041101-2015-00020
Device Sequence Number1
Product Code JES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number8137109128
Device Lot Number1303D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2015
Is the Reporter a Health Professional? No
Event Location Other
Date Manufacturer Received06/28/2015
Was Device Evaluated by Manufacturer? Yes
Removal/Correction NumberNI
Patient Sequence Number1
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