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 2020-02-11 for SPACEOAR SYSTEM SO-2101 manufactured by Augmenix, Inc..
[178562362]
The complainant was unable to provide the suspect device lot number. Therefore, the expiration and device manufacture dates are unknown. User facility number: mw5080315. (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
[178562363]
It was reported to boston scientific corporation on january 21, 2020 that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2018. According to the complainant, the spaceoar gel was noted to be present in the rectum. The patient experienced ulceration and severe bleeding requiring a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00378 |
| MDR Report Key | 9693370 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2018-09-29 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-11 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2020-02-11 |
| 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 | 2020-02-11 |