MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-27 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[19164390]
Two days after her third prosorba treatment, the patient developed retrosternal chest pain. She had angiogram and a stent was placed in the rivp (right posterior descending coronary artery). She had a histroy of high cholesterol, hypertension and chest pain which improved with nitroglycerin. Prior to 2004 she had a diagnosis of posterior myocardial infarction and she had a stent place in the right coronary artery in 2004. This adverse event occurred in another country and we have been unable to obtain the lot number of the prosorba column used in the last treatment.
Patient Sequence No: 1, Text Type: D, B5
[19515318]
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 the cause of her hypotension and electrolyte imbalance was not known and stated to possibly be due to a renal abnormality related to her underlying condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00009 |
| MDR Report Key | 745034 |
| Report Source | 05 |
| Date Received | 2006-07-27 |
| Date of Report | 2006-07-27 |
| Date of Event | 2006-05-18 |
| Report Date | 2006-07-25 |
| Date Mfgr Received | 2006-06-27 |
| Date Added to Maude | 2006-08-09 |
| 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 | IMMUNOADSORPTION |
| Product Code | LQQ |
| Date Received | 2006-07-27 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 732822 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-07-27 |