MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-05 for TOTAL PROTEIN KIT, MIRCO LOWRY REAGENT, PETERSON'S MODIFICATION 49468567 TP0300-1KT manufactured by Sigma-aldrich.
[689650]
In 2007, we rec'd a product purchased. The box containing the chemicals was not labeled with any warnings or special handling instructions. One of our employees opened the box, and discovered that the lowry reagent was loose in the box. Opening the box caused the reagent to become airborne and subsequently inhaled by the employee opening the box. Dose or amount: 1 kit, diagnosis or reason for use: chemical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004069 |
| MDR Report Key | 928129 |
| Date Received | 2007-10-05 |
| Date of Report | 2007-10-05 |
| Date of Event | 2007-08-14 |
| Date Added to Maude | 2009-04-22 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTAL PROTEIN KIT, MIRCO LOWRY REAGENT, PETERSON'S MODIFICATION |
| Generic Name | LOWRY REAGENT |
| Product Code | JGP |
| Date Received | 2007-10-05 |
| Model Number | 49468567 |
| Catalog Number | TP0300-1KT |
| Lot Number | 057K6813 |
| ID Number | 826441471 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIGMA-ALDRICH |
| Manufacturer Address | 3050 SPRUCE ST ST. LOUIS MO 63103 US 63103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2007-10-05 |