MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for TEST FOR SYPHILIS * manufactured by Serologicals. Inc..
[16138054]
Md was calling to alert fda that he feels that mfr has poor or deficient test procedures for syphilis. He explained that a pt of his donated plasma and they told him he was positive for syphilis. Md ran a subsequent test which was negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001768 |
| MDR Report Key | 68198 |
| Date Received | 1997-02-12 |
| Date of Report | 1996-11-01 |
| Date Added to Maude | 1997-02-13 |
| 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 | 0 |
| 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 | TEST FOR SYPHILIS |
| Generic Name | TEST SYPHILIS |
| Product Code | GMT |
| Date Received | 1997-02-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 68201 |
| Manufacturer | SEROLOGICALS. INC. |
| Manufacturer Address | 445 BILTMORE AVE ASHEVILLE NC 28801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-02-12 |