MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-19 for HIVAB HIV-1/HIV-2 (RDNA) EIA 3A77-78 manufactured by Abbott Laboratories.
| Report Number | 1415939-2008-00498 |
| MDR Report Key | 1125665 |
| Report Source | 05 |
| Date Received | 2008-08-19 |
| Date of Report | 2008-07-29 |
| Date of Event | 2008-07-07 |
| Date Mfgr Received | 2008-07-29 |
| Date Added to Maude | 2009-02-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. KHAUDEJA BANO, MD, D-09Y6, AP6C-2 |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 600646112 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646112 |
| Manufacturer Phone | 8479386319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIVAB HIV-1/HIV-2 (RDNA) EIA |
| Generic Name | EIA FOR DETECTION OF AB TO HIV I AND II |
| Product Code | LRM |
| Date Received | 2008-08-19 |
| Model Number | NA |
| Catalog Number | 3A77-78 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |