MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-21 for EMBOSPHERE MICROSPHERES manufactured by Biosphere Medical Sa.
[40745938]
Patient Sequence No: 1, Text Type: N, H10
[40745939]
A (b)(6) underwent embolization of the prostate for treatment of benign prostatic hyperplasia. Embosphere microspheres were used as the embolic agent. Immediately after the procedure a full body rash developed. The patient had taken most of the other medications that had been administered previously, suggesting they weren't the etiology of the reaction. Rash became desquamating over the next few days and there are still multiple erythematous patches remaining several months after the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5513247 |
| MDR Report Key | 5513247 |
| Date Received | 2016-03-21 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-01-26 |
| Report Date | 2016-03-17 |
| Date Reported to FDA | 2016-03-17 |
| Date Reported to Mfgr | 2016-03-17 |
| Date Added to Maude | 2016-03-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Product Code | NAJ |
| Date Received | 2016-03-21 |
| Lot Number | 1575929 |
| Device Expiration Date | 2018-03-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL SA |
| Manufacturer Address | US AGENT: JOHN KNORPP MERIT MEDICAL SYSTEMS, INC. 1600 MERIT PARKWAY SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-21 |