MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-02-24 for REVEAL G2 RAPID HIV-1 * 815311000249 manufactured by Medmira Laboratories.
[18917226]
Opened 1 kit lot # r21a0045 exp date 12/2005 and 2 kits of lot# r21a0035 exp date 11/2005 to find plastic bag where buffer stored wet and labels on the buffer rubbing so unreadable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034790 |
| MDR Report Key | 578516 |
| Date Received | 2005-02-24 |
| Date of Report | 2005-02-23 |
| Date of Event | 2005-02-23 |
| Date Added to Maude | 2005-03-08 |
| 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 | 3 |
| 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 | REVEAL G2 RAPID HIV-1 |
| Generic Name | TEST KIT FOR PT SAMPLES |
| Product Code | MWB |
| Date Received | 2005-02-24 |
| Model Number | * |
| Catalog Number | 815311000249 |
| Lot Number | R21A0045 |
| ID Number | * |
| Device Expiration Date | 2005-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568365 |
| Manufacturer | MEDMIRA LABORATORIES |
| Manufacturer Address | 155 CHAIN LAKE DR STE 1 HALIFAX, NOVA SCOTIA CA |
| Brand Name | REVEAL G2 RAPID HIV-1 |
| Generic Name | TEST KIT FOR PATIENT SAMPLES |
| Product Code | MWB |
| Date Received | 2005-02-24 |
| Model Number | * |
| Catalog Number | 815311000249 |
| Lot Number | R21A0035 |
| ID Number | * |
| Device Expiration Date | 2005-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 568367 |
| Manufacturer | MEDMIRA LABORATORIES |
| Manufacturer Address | 155 CHAIN LAKE DR STE 1 HALIFAX, NOVA SCOTIA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-02-24 |