MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-05-25 for EMBOSPHERE MICROSPHERES S620GH/JPA manufactured by Biosphere Medical Sa.
[76020851]
The suspect device is not expected to return for evaluation. A review of the complaint database and device history record could not be performed since the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[76020852]
The account reported that a uterine artery embolization was performed on (b)(6) 2017. On (b)(6) 2017 pyrexia, pollakiuria, painful micturition and low back pain developed. The next day the patient made an after-hours visit to the hospital. Pyelonephritis was diagnosed, and levofloxacin hydration was prescribed. Pyrexia repeatedly developed after the visit. On (b)(6) 2017, the patient visited the hospital again. Ultrasonography showed an improvement in hydronephrosis. Moreover, no findings suggestive of abscess formation was noted on emergency computed tomography. Follow-up observation for inflammatory reaction was performed. On (b)(6) 2017 myoma expulsion was noted. The patient pulled out the myoma with her own hands. On (b)(6) 2017 myoma expulsion was still noted. It also had a strange odor and no improvement was confirmed. The patient thus visited the hospital again with lower abdominal pain. The length of the myoma expelled outside the vagina was about 10 cm. Marked abdominal bloating was noted. The expelled myoma was removed as much as possible on an outpatient basis, but the removal was far from complete. Pyrexia developed again and the patient was urgently hospitalized. Blood culture yielded negative results. Administration of sulbactam/ampicillin (sbt/abpc) at 3g 3 time per day was initiated. On (b)(6) 2017 vaginal expulsion of a part of the myoma was noted and a part of the myoma was removed using cooper scissors and colposcope. No percussion pain was noted. Pyrexia started to develop again after the procedure. On (b)(6) 2017 persistent spike fever was noted. A discussion with the patient and her husband was held and a decision was made to perform total abdominal hysterectomy (tah). On (b)(6) 2017 (24 days after uae) semi-urgent tah, bilateral salpingectomy, and left cystectomy was performed. Hemodilution due to fluid therapy performed at the start of surgery resulted in decreased hemoglobin levels and transfusion of red cell concentrates (4 units) was performed. The surgery required 2 hours and 58 minutes to be completed. The amount of bleeding was 650 ml and the weight of the removed specimen was (b)(6). On (b)(6) 2017 (postoperative day 5) a drainage tube in the douglas' pouch was removed and antibiotic therapy was discontinued. On (b)(6) 2017 (postoperative day 10) no findings suggestive of infection were noted in the wounded area or abdomen and the patient was discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615728-2017-00019 |
| MDR Report Key | 6592931 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-05-25 |
| Date of Report | 2017-05-09 |
| Date of Event | 2017-02-26 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-05-25 |
| 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 | MR. CASEY HUGHES, MS, CQE, CSQP |
| Manufacturer Street | 1600 WEST MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer G1 | BIOSPHERE MEDICAL SA |
| Manufacturer Street | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE |
| Manufacturer City | 95700 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 95700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMBOSPHERE MICROSPHERES |
| Generic Name | MICROSPHERES |
| Product Code | NAJ |
| Date Received | 2017-05-25 |
| Catalog Number | S620GH/JPA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSPHERE MEDICAL SA |
| Manufacturer Address | PARC DES NATIONS, PARIS NORD 2 383, RUE DE LA BELLE ETOILE 95700 FR 95700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-05-25 |