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 2020-02-03 for SPACEOAR SYSTEM SO-4101 manufactured by Augmenix, Inc..
[177600228]
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown. However, the complainant reported that the device was not expired. (b)(4). The complainant indicated that the device was disposed 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
[177600229]
It was reported to boston scientific corporation that spaceoar was implanted during a spaceoar placement procedure performed on (b)(6) 2020. A metal marker was also placed prior to implanting spaceoar. Reportedly, lidocaine was used for local anesthesia. According to the complainant, following the procedure, the patient's blood pressure and consciousness level decreased. The patient was sent to the intensive care unit (icu) for treatment. The patient experienced an allergic reaction, and a rash was noted by the treating physician. The patient received an intramuscular epinephrine injection and remained under observation. In the physician's assessment, the cause of the patient's allergic reaction could not be confirmed. There were no further patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable. The patient was discharged from the hospital on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2020-00283 |
| MDR Report Key | 9662316 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-05-20 |
| 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-4101 |
| Catalog Number | SO-4101 |
| Lot Number | 0005201901 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-03 |