FDA.reportPublic FDA data

MAUDE MDR 7042559

MDR report key
7042559
Report number
1038758-2017-00044
Event key
0
Event type
3
Date of event
2017-10-27
Date received
2017-11-17
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. FEDERICO JULIAO
Address
300 SARASOTA CENTER BLVD. SARASOTA FL 34240 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CVS PHARMACYELASTIC STRETCH NETSHANDONG SINCERE MEDICAL PRODUCTS CO., LTD.FQMUPC#0504282665408941173099-100812Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-170

Event Narratives#

N

Patient 1

AS OF 11/14/2017 ASO REVIEWED RECORDS FOR PHYSICAL PROPERTIES PERFORMED ON PRE-SHIPMENT SAMPLES OF THE SAME LOT NUMBER WITH RESULTS ACCEPTABLE IN ADDITION TO EVALUATE THE BIOCOMPATIBILITY STUDIES AND LATEX SCREENING. COMPLAINT DATABASE WAS REVIEWED; THERE WAS NO NEGATIVE TREND IDENTIFIED FOR THE ASSOCIATED PRODUCT. TRENDING IS COMPLETED ON ALL PRODUCTS MONTHLY.

D

Patient 1

CONSUMER STATED THAT PRODUCT CAUSED HER BLISTERS AND RASH AROUND THE AREA WHERE SHE HAD A BIOPSY. CONSUMER ASKED IF THE PRODUCT CONTAINS LATEX.