EQUATE UPC#681131006712 566928030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-02-21 for EQUATE UPC#681131006712 566928030 manufactured by Aso Llc.

Event Text Entries

[188552445] As of 02/14/2020 aso has not received returned product or lot number information from the consumer for further investigation. Satisfactory biocompatibility test results and latex screenings for the materials used to manufacture the same type of products were reviewed. Refer to b. 6 for further details.
Patient Sequence No: 1, Text Type: N, H10


[188552446] On the initial report on 01/23/2020 consumer stated the bandages caused her an allergic reaction. Consumer added sought medical attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038758-2020-00009
MDR Report Key9741622
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-02-21
Date of Report2020-03-06
Date of Event2020-01-23
Date Mfgr Received2020-01-23
Device Manufacturer Date2019-11-19
Date Added to Maude2020-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. FEDERICO JULIAO
Manufacturer Street300 SARASOTA CENTER BLVD.
Manufacturer CitySARASOTA, FL
Manufacturer CountryUS
Manufacturer G1ASO LLC
Manufacturer Street300 SARASOTA CENTER BLVD.
Manufacturer CitySARASOTA, FL
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUATE
Generic NameFLEXIBLE FABRIC BANDAGES ANTIBACTERIAL
Product CodeKGX
Date Received2020-02-21
Model NumberUPC#681131006712
Catalog Number566928030
Lot Number00117018
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASO LLC
Manufacturer Address300 SARASOTA CENTER BLVD. SARASOTA, FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.