EQUATE UPC#681131006736 566928026

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 2020-02-12 for EQUATE UPC#681131006736 566928026 manufactured by Aso Llc.

Event Text Entries

[188554157] The initial complaint by the customer did not indicate that an mdr would be required. However, per the info received on 01/14/2020 consumer stated would seek medical treatment. Based on the information received, aso opted to file an mdr. As of 02/11/2020 unused retained samples of the same lot as the product reported and returned product were submitted to the lab for testing with no defects noted. In addition, aso reviewed records of biocompatibility tests with no issues noted. Refer to section b. 6 of this report for further details.
Patient Sequence No: 1, Text Type: N, H10


[188554158] On the initial report of (b)(6) 2019 consumer stated that product caused rash in the shape of the bandage. On 01/14/2020 aso received completed cir where consumer stated will seek medical attention.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038758-2020-00007
MDR Report Key9700890
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-02-12
Date of Report2020-01-14
Date of Event2019-12-17
Date Mfgr Received2019-12-17
Device Manufacturer Date2019-08-15
Date Added to Maude2020-02-12
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 NameHEAVY DUTY FABRIC BANDAGES ANTIBACTERIAL
Product CodeKGX
Date Received2020-02-12
Model NumberUPC#681131006736
Catalog Number566928026
Lot Number00112037
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASO LLC
Manufacturer Address300 SARASOTA CENTER BLVD. SARASOTA, FL US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-12

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