FDA Adverse Event Malfunction Summary report: N

REACH JOHNSON & JOHNSON FLOSS FLOURIDE MINT WAXED

MDR report key: 2250569 · Received September 16, 2011

Report

Report Number
8041101-2011-00003
Event Type
Malfunction
Date Received
September 16, 2011
Report Date
September 16, 2011
Manufacturer
JOHNSON & JOHNSON CONSUMER PRODUCTS
Product Code
JES
Removal / Correction Number
NI
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

Description of Event or Problem · 1

THIS SPONTANEOUS REPORT WAS RECEIVED ON 23-AUG-2011 CONCERNING A CONSUMER (AGE AND GENDER UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER NOTICED THAT DISPENSER OF REACH JOHNSON & JOHNSON FLOSS FLUORIDE MINT WAXED (LOT NUMBER: 3480D AND EXPIRATION DATE: UNSPECIFIED) POPPED OFF AND THE PART THAT HAD CUTTER CAME OFF. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS NOT APPLICABLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 REACH JOHNSON & JOHNSON FLOSS FLOURIDE MINT WAXED DENTAL FLOSS JES JOHNSON & JOHNSON CONSUMER PRODUCTS REFFMWUS 3480D

Patients

Seq Age Sex Outcome Treatment
1