FDA.reportPublic FDA data

MAUDE MDR 9539701

MDR report key
9539701
Report number
1645337-2020-00078
Event key
0
Event type
3
Date of event
2019-12-06
Date received
2020-01-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. GABRIEL ALFAGEME
Address
3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PSI-TECIII ASPIRATOR 110V,STNDSYSTEM, SUCTION, LIPOPLASTYMENTOR TEXASMUUPT-ASP-III-110N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-020

Event Narratives#

N

Patient 1

SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER?S REFERENCE NUMBER: (B)(4).

D

Patient 1

IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V WAS CONTINUALLY BLOWING AND MELTING FUSES UPON USE. IT JUST STARTED HAPPENING. NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED AT THIS TIME.