MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-13 for SPACEOAR SYSTEM SO-2101 manufactured by Augmenix, Inc..
[181750468]
No event date was given, therefore an approximate date of (b)(6) 2019 was used as the event date based on the event comments of "approximately week 5 of treatment. " the complainant was unable to provide the suspect device lot number. Therefore, the expiration and device manufacture dates are unknown. 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
[181750469]
It was reported to boston scientific corporation on january 24, 2020 that spaceoar was implanted by a urologist in the perirectal fat during a spaceoar implant procedure performed on (b)(6) 2019. Reportedly, fiducial marker was implanted together with spaceoar and there were no issues noted during spaceoar placement. According to the complainant, approximately five weeks into the radiation treatment the patient complained of loose stool and discomfort during bowel movement that continued through week eight of the treatment. On (b)(6) 2019 the patient was examined upon completion of his radiation therapy and complained of gastrointestinal discomfort. On (b)(6) 2020 the patient had colonoscopy and an ulcerated abnormality that looked like a fistula tract was noted. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00425 |
| MDR Report Key | 9706475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-02-13 |
| 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 | 2020-02-13 |
| Model Number | SO-2101 |
| Catalog Number | SO-2101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-13 |