FDA.reportPublic FDA data

MAUDE MDR 6332866

MDR report key
6332866
Report number
3008513398-2016-00002
Event key
0
Event type
3
Date of event
2016-09-07
Date received
2017-02-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. KAL FISHMAN
Address
851 BROKEN SOUND PARKWAY NW #215 BOCA RATON FL 33487 US
Phone
561-561-5619
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SENSUS HEALTHCARE SRT-100SYSTEM, THERAPEUTIC, X-RAYSENSUS HEALTHCAREJADSRT-100SRT-100Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-1501. O

Event Narratives#

N

Patient 1

THE SRT-100 SYSTEM USED TO DELIVER THERAPY OPERATED WITHIN ITS NORMAL DESIGN PARAMETERS. NO ISSUES ASSOCIATED WITH THIS SYSTEM HAVE BEEN NOTED DURING THE INITIAL REVIEW MANUFACTURING TESTING, INSPECTION, INSTALLATION, AND SERVICING RECORDS.

D

Patient 1

WOUND/SORE AT TREATMENT SITE (APPLICATION OF SUPERFICIAL RADIOTHERAPY FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMA). SENSUS HEALTHCARE RECEIVED A CALL FROM USER FACILITY DURING THE FIRST WEEK IN SEPTEMBER STATING THAT A PATIENT RETURNED AFTER COMPLETING TREATMENT FOR A SQUAMOUS CELL CARCINOMA (SCC) ON HER DORSAL HAND WITH BREAKDOWN TO THE AREA. PROVIDER STATED THE PATIENT WAS WEARING WORK GLOVES EVERYDAY POST TREATMENT AND WONDERED IF THIS COULD BE THE CAUSE OF THE BREAKDOWN. WE DISCUSSED HOW THE BIOLOGIC RESPONSES CONTINUE ON FOR SEVERAL WEEKS AND HOW WEARING THE GLOVES MAY HAVE CONTRIBUTED TO THE BREAKDOWN. SHORTLY AFTER SENSUS HEALTHCARE RECEIVED A PHONE CALL FROM PHYSICIAN EXPLAINING THAT THE PATIENT DID NOT RETURN WITH BREAKDOWN, THAT THE PATIENT RETURNED DUE TO RE-OCCURRENCE IN THE SAME AREA. THE QUESTION ASKED WAS; "COULD THIS PATIENT'S RE-OCCURRENCE BE CAUSED BY WEARING GLOVES THROUGHOUT AND POST TREATMENT? SENSUS HEALTHCARE REQUESTED THE PATIENT'S PATHOLOGY REPORT, FRACTION LOG AND PHOTOS FOR FURTHER EVALUATION. NOTE: PROVIDER CONFIRMED THAT THE LESION WAS DECREASING IN SIZE WHILE UNDER TREATMENT AND THE PATIENT TOLERATED THE TREATMENT WELL.