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 2020-02-03 for SPACEOAR SYSTEM SO-2101 manufactured by Augmenix, Inc..
[177644172]
No event date was provided, therefore an approximate date of (b)(6) 2019 was used as the event date based on the event comments of "in december. " the complainant was unable to provide the suspect device lot number. Therefore, the manufacture date and expiration date are unknown. (b)(4). The device has been 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
[177644173]
It was reported to boston scientific corporation on january 10, 2020 that spaceoar was implanted during a spaceoar placement procedure performed in (b)(6) 2019. Reportedly, the procedure was done under local anesthesia and there were no issues noted during spaceoar placement. According to the complainant, in december 2019, the patient experienced pain, urinary urgency, urinary frequency, and incontinence. In the physician's assessment the patient's symptoms were related to the spaceoar device. A colonoscopy was performed and a sinus tract was noted. Medication was provided to treat the urinary urgency and urinary frequency. A procedure was performed that was intended to reduce side effects and improve quality of life. As of (b)(6) 2020, the patient is under disability due to his symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00279 |
| MDR Report Key | 9661172 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| 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 | 2020-02-03 |