FDA.reportPublic FDA data

MAUDE MDR 2727096

MDR report key
2727096
Report number
MW5026761
Event key
0
Event type
3
Date of event
2012-08-12
Date received
2012-08-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WATER PIKWATER FLOSSERWATER PIKEFSWP-100W/WP-100C Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-160

Event Narratives#

D

Patient 1

ON (B)(6) 2012, THE CONSUMER WAS USING THE WATER PIK FLOSSER ON HER UPPER RIGHT BACK TEETH WHEN THE FLOSSER AUTOMATICALLY WENT ON FULL PRESSURE. THE FLOSSER SLIPPED FROM HER HAND AND RIPPED THE SKIN FROM THE INSIDE OF HER JAW. SHE STATED THAT THIS IS THE FIRST TIME THAT IT HAPPENED. ON (B)(6) 2012, THE CONSUMER STATED THAT IT WOULD NOT STOP BLEEDING SO SHE CALLED HER DENTIST AND WAS ADVISED TO RINSE HER MOUTH IN SALT WATER. THE CONSUMER STATED THAT SHE LATER DISCOVERED A MASS AMOUNT OF LOOSE SKIN WHERE HER INSIDE JAW WAS RIPPED. THE CONSUMER STATED THAT SHE CALLED THE RETAILER ((B)(4)) AND WAS TOLD TO BRING THE PRODUCT IN FOR A NEW ONE. SHE DID NOT CONTACT THE MFR BUT WILL IN THE FUTURE. PURCHASE DATE: (B)(6) 2012. THE PRODUCT WAS NOT DAMAGED OR MODIFIED BEFORE THE INCIDENT.