MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-12-07 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[554362]
Patient developed shortness of breath the evening after his second prosorba treatment. He was admitted to the hospital and diagnosed with exacerbation of his pre-existing chronic obstructive pulmonary disease and a left upper lobe solitary pulmonary nodule. He was treated with iv antibiotics, corticosteroids, nebulizers, inhalers and oxygen. This patient has a long history of copd, granulomatous disease and possible tb. His medical history also includes peripheral neuropathy, gerd and anxiety. He was discharged after 1 week.
Patient Sequence No: 1, Text Type: D, B5
[7940444]
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 would suggest a contributory relationship. The prosorba column package insert lists dyspnea/shortness of breath as a possible side effect of these procedures. Patients with pulmonary disease can have difficulty tolerating fluids shifts that occur with extracorporeal procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3032792-2006-00019 |
| MDR Report Key | 793532 |
| Report Source | 05 |
| Date Received | 2006-12-07 |
| Date of Report | 2006-12-07 |
| Date of Event | 2006-09-02 |
| Report Date | 2006-12-06 |
| Date Reported to Mfgr | 2006-11-13 |
| Date Mfgr Received | 2006-11-13 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2006-12-14 |
| 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 COLUMN |
| Product Code | LQQ |
| Date Received | 2006-12-07 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RDN001E |
| ID Number | NA |
| Device Expiration Date | 2006-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 781151 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Baseline Brand Name | PROSORBA COLUMN |
| Baseline Generic Name | THERAPEUTIC PLASMA EXCHA |
| Baseline Catalog No | 9798701 |
| Baseline Device Family | PROTEIN A IMMUNOADSORPTION COL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-12-07 |