MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-24 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[502287]
Patient admitted with chest pain 4 days after his 4th prosorba treatment. He was diagnosed with a blockage in the left main coronary artery during cardiac catheterization in 2006. Another cardiac cath was performed five days later and a stent was placed. After this second catheterization, the patient developed renal abnormalities thought to be due to contrast media likely due to radiocontrast used for the catheterizations. Medical history includes coronary artery disease with stent placement in 2000, obesity, immobility (must use walker), history of smoking, iddm and intermittent chest pain which usually sibsides with ntg. Symptoms resolved and patient was discharged. Patient resumed prosorba treatments the following month and has had no recurrence of symptoms.
Patient Sequence No: 1, Text Type: D, B5
[7792761]
This investigation is a clinical investigation only. Return of product not requested as evaluation of device after use not relevant to reported event. The device was used according to labeled indications and in the appropriate environment. Temporal relationship of the event and prosorba might suggest a contributory relationship however this patient's chest pain was likely related to his underlying cardiac condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00011 |
| MDR Report Key | 755283 |
| Report Source | 05 |
| Date Received | 2006-08-24 |
| Date of Report | 2006-08-24 |
| Date of Event | 2006-07-23 |
| Report Date | 2006-08-24 |
| Date Mfgr Received | 2006-07-25 |
| Device Manufacturer Date | 2005-07-01 |
| Date Added to Maude | 2006-08-30 |
| 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 | JOSHUA LASKER |
| Manufacturer Street | 14715 NE 95TH ST. STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4252422154 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSORBA COLUMN |
| Generic Name | PROSORBA COLUMN |
| Product Code | LQQ |
| Date Received | 2006-08-24 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RGN001C |
| ID Number | * |
| Device Expiration Date | 2007-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 743102 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-08-24 |