FDA.reportPublic FDA data

MAUDE MDR 7629606

MDR report key
7629606
Report number
2016150-2018-00025
Event key
0
Event type
3
Date received
2018-06-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PAULO CALLE
Address
1717 W COLLINS AVENUE ORANGE CA 92867 US
Phone
714-714-7145
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYBRONENDOFINE BUCHANAN PLUGGERSYBRONENDOEKR952-0004R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-220

Event Narratives#

N

Patient 1

NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO AGE, SEX, WEIGHT, ETHNICITY, AND RACE. DATE OF EVENT WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED IN REGARDS TO THE SERIAL NUMBER, THEREFORE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. THIS WILL BE FOUR (4) OF TWENTY-FOUR (24) MEDICAL DEVICE REPORTS THAT WILL BE SUBMITTED. THE PRODUCT HAS BEEN IDENTIFIED AS AN AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.

D

Patient 1

AN ALLEGED COMPLAINT WAS REPORTED THAT MULTIPLE PATIENTS SUFFERED A TOUGHER POST-OPERATIVE RECOVERY. THEY FELT A VERY HIGH SENSITIVITY DUE TO HIGHER HEAT.