ACCUSHAPE ACSS-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-26 for ACCUSHAPE ACSS-001 manufactured by Medcad.

MAUDE Entry Details

Report Number3009196021-2019-00005
MDR Report Key8737659
Report SourceDISTRIBUTOR
Date Received2019-06-26
Date of Report2019-06-24
Date of Event2018-05-21
Date Mfgr Received2018-05-24
Device Manufacturer Date2018-05-18
Date Added to Maude2019-06-26
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 ContactMS. ESTELLE ANUWE
Manufacturer Street501 S. 2ND AVE. SUITE A1000
Manufacturer CityDALLAS TX 75226
Manufacturer CountryUS
Manufacturer Postal75226
Manufacturer Phone2144538864
Manufacturer G1MEDCAD
Manufacturer Street501 S. 2ND AVE. SUITE A1000
Manufacturer CityDALLAS TX 75226
Manufacturer CountryUS
Manufacturer Postal Code75226
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCUSHAPE
Generic NamePEEK PATIENT-SPECIFIC IMPLANT
Product CodeGXN
Date Received2019-06-26
Catalog NumberACSS-001
Lot Number182312 SIN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDCAD
Manufacturer Address501 S. 2ND AVE. SUITE A1000 DALLAS TX 75226 US 75226


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-26

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