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 2020-03-26 for SPACEOAR SYSTEM SO-1010 manufactured by Augmenix, Inc..

Event Text Entries

[185121207] The exact date of the event is unknown. The provided event date, (b)(6) 2020, was chosen as a best estimate based on the date that the manufacturer became aware of the event, 03/09/2020. The reported lot number could not be confirmed; therefore, the manufacture date and expiration date are unknown. (b)(4). The device was implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[185121208] It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on an unknown date. Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement. According to the complainant, post procedure magnetic resonance imaging (mri) showed that the spaceoar gel had travelled up and around the prostate. There were no patient complications reported as a result of this event. The patient condition after the procedure was reported to be stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2020-01059
MDR Report Key9884832
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-01
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 Received2020-03-26
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 2020-03-26

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