MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-26 for GENETIC SYSTEMS HIV-1 WESTERN BLOT 32508 manufactured by Bio-rad Laboratories.
[20156248]
A laboratory technologist at a customer site was splashed in the eye with the low positive control from the genetic systems hiv-1 western blot kit. The technologist sought medical care as a precaution. The customer requested information regarding heat inactivation. This information was faxed the next day and sent by fedex. The customer verified receipt and indicated that no further information was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2002-00001 |
| MDR Report Key | 391276 |
| Report Source | 05 |
| Date Received | 2002-04-26 |
| Date of Report | 2002-04-22 |
| Date of Event | 2002-04-11 |
| Date Mfgr Received | 2002-04-11 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2002-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTOPHER BENTSEN |
| Manufacturer Street | 6565 185TH AVENUE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981709 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENETIC SYSTEMS HIV-1 WESTERN BLOT |
| Generic Name | WESTERN BLOT, IVD |
| Product Code | MVW |
| Date Received | 2002-04-26 |
| Model Number | NA |
| Catalog Number | 32508 |
| Lot Number | 915453 |
| ID Number | NA |
| Device Expiration Date | 2003-01-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 380325 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 6565 185TH AVE., N.E. REDMOND WA 98052 US |
| Baseline Brand Name | GENETIC SYSTEMS HIV-1 WESTERN BLOT |
| Baseline Generic Name | HUMAN IMMUNODEFICIENCY VIRUS TYPE I |
| Baseline Model No | NA |
| Baseline Catalog No | 32508 |
| Baseline ID | LOT #915453 |
| Baseline Device Family | GENETIC SYSTEMS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-26 |