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 2020-01-30 for SPACEOAR SYSTEM SO-2101 manufactured by Augmenix, Inc..
[178607983]
The complainant was unable to report the lot number; 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
[178607984]
It was reported to boston scientific corporation on january 6, 2020 that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2019. Reportedly, the patient underwent stereotactic body radiation therapy (sbrt) for 45 gray (gy) in 5 fractions of 9 gy each. The patent also had an adjacent indeterminate r anterior pubic bone lesion incorporated in the 35 gy isodose line. According to the complainant, during magnetic resonance imaging (mri) post procedure, mild infiltration of the gel into the rectal wall was noted. On (b)(6) 2019, around five months post spaceoar placement, the patient complained of rectal pain. A sigmoidoscopy was performed on (b)(6) 2019, during which a large ulceration was noted in the area right behind the prostate in the rectum. On (b)(6) 2019, the patient underwent a diverting colostomy procedure. On (b)(6) 2020, the patient started hyperbaric oxygen therapy. As of (b)(6) 2020, the patient continues to have some blood and mucous discharge from the rectum. The patient's pain, rectal symptoms, and urinary symptoms continue to improve with the colostomy in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00210 |
| MDR Report Key | 9647416 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-04-23 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-30 |
| 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 | 2020-01-30 |
| Model Number | SO-2101 |
| Catalog Number | SO-2101 |
| 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. Required No Informationntervention | 2020-01-30 |