MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for PVA FOAM EMBOLIZATION PARTICLES UNKNOWN manufactured by Cook Inc.
[89288878]
It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" related to a retrospective review of patients from 2005 to 2013, that liver abscesses were found in 21 out of 3613 patients who had undergone a transarterial chemoembolization (tace) procedure. The patients had hepatic malignancies. Among the 21 patients, 15 were males and 6 were females, ranging in age from 41 to 73 years (mean 54. 6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03482 |
| MDR Report Key | 6947602 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-12-07 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2017-11-09 |
| Date Added to Maude | 2017-10-13 |
| 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. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PVA FOAM EMBOLIZATION PARTICLES |
| Generic Name | AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS |
| Product Code | NAJ |
| Date Received | 2017-10-13 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-13 |