MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-07-12 for HOME ACCESS HIV-1 TEST SYSTEM EXPRESS 24000 manufactured by Home Access Health Corp..
[182667]
Client's sibling pricked finger while helping client cleanup.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423455-2000-00001 |
| MDR Report Key | 285887 |
| Report Source | 04 |
| Date Received | 2000-07-12 |
| Date of Report | 2000-07-12 |
| Date of Event | 2000-06-08 |
| Date Mfgr Received | 2000-06-28 |
| Date Added to Maude | 2000-07-18 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RICHARD BROWN, DIRECTOR |
| Manufacturer Street | 2401 W HASSELL RD STE 1510 |
| Manufacturer City | HOFFMANN ESTATES IL 601955200 |
| Manufacturer Country | US |
| Manufacturer Postal | 601955200 |
| Manufacturer Phone | 8477812526 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME ACCESS HIV-1 TEST SYSTEM |
| Generic Name | HOME HIV COLLECTION KIT |
| Product Code | MVZ |
| Date Received | 2000-07-12 |
| Model Number | EXPRESS |
| Catalog Number | 24000 |
| Lot Number | 982008 |
| ID Number | * |
| Device Expiration Date | 2000-08-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276654 |
| Manufacturer | HOME ACCESS HEALTH CORP. |
| Manufacturer Address | 2401 W. HASSELL RD. SUITE 1510 HOFFMAN ESTATES IL 601955200 US |
| Baseline Brand Name | HOME ACCESS EXPRESS HIV-1 TEST SYSTEM |
| Baseline Generic Name | HOME ACCESS EXPRESS |
| Baseline Model No | 24000 |
| Baseline Catalog No | NA |
| Baseline ID | EXPRESS KIT |
| Baseline Device Family | HOME ACCESS EXPRESS HIV-1 TEST SYSTEM |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-12 |