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 2019-11-06 for SPACEOAR SYSTEM SO-1010 manufactured by Augmenix, Inc..
Report Number | 3005099803-2019-05262 |
MDR Report Key | 9287373 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-06 |
Date of Report | 2019-11-06 |
Date of Event | 2019-05-07 |
Date Mfgr Received | 2019-10-10 |
Date Added to Maude | 2019-11-06 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | CAROLE MORLEY |
Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
Manufacturer City | MARLBOROUGH MA 01752 |
Manufacturer Country | US |
Manufacturer Postal | 01752 |
Manufacturer Phone | 5086834015 |
Manufacturer G1 | AUGMENIX, INC. |
Manufacturer Street | 201 BURLINGTON ROAD |
Manufacturer City | BEDFORD MA 01730 |
Manufacturer Country | US |
Manufacturer Postal Code | 01730 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SPACEOAR SYSTEM |
Generic Name | ABSORBABLE PERIRECTAL SPACER |
Product Code | OVB |
Date Received | 2019-11-06 |
Model Number | SO-1010 |
Catalog Number | SO-1010 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | AUGMENIX, INC. |
Manufacturer Address | 201 BURLINGTON ROAD BEDFORD MA 01730 US 01730 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-11-06 |