MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-01 for * manufactured by Zlb Plasma Services.
[321139]
Consumer reports that while donating plasma at a local plasma center they were splattered with blood from another pt that was seated near them. Blood made contact with the consumer's arm in which they were donating from and also on their clothing. Pt is concerned that they may be in danger of contracting a disease from this incident, as well as concerns about how this could happen at a plasma facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003701 |
| MDR Report Key | 526453 |
| Date Received | 2004-04-28 |
| Date of Report | 2004-04-01 |
| Date Added to Maude | 2004-05-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | BLOOD/PLASMA PRODUCT |
| Product Code | KST |
| Date Received | 2004-04-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515617 |
| Manufacturer | ZLB PLASMA SERVICES |
| Manufacturer Address | 215 ASSEMBLY ST COLUMBIA SC 292014240 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-04-28 |