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..
[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
| Report Number | 3005099803-2020-01059 |
| MDR Report Key | 9884832 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 2020-03-26 |
| 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 | 2020-03-26 |