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 |