SPACEOAR SYSTEM SO-1010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for SPACEOAR SYSTEM SO-1010 manufactured by Augmenix, Inc..

MAUDE Entry Details

Report Number3005099803-2019-05846
MDR Report Key9392004
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-03-01
Date Mfgr Received2019-11-01
Date Added to Maude2019-11-29
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 ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1AUGMENIX, INC.
Manufacturer Street201 BURLINGTON ROAD
Manufacturer CityBEDFORD MA 01730
Manufacturer CountryUS
Manufacturer Postal Code01730
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPACEOAR SYSTEM
Generic NameABSORBABLE PERIRECTAL SPACER
Product CodeOVB
Date Received2019-11-29
Model NumberSO-1010
Catalog NumberSO-1010
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAUGMENIX, INC.
Manufacturer Address201 BURLINGTON ROAD BEDFORD MA 01730 US 01730


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-29

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