MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-30 for TC-CW manufactured by Bioscience Tools.
[2789737]
(b)(4). Who you are: consumer. Incident: i purchased a model, model tc-cw incubator from (b)(6), located in (b)(6) description: the quality of this product is so poor that it presents a safety hazard after arrival via normal shipping. The circuity of the product appears to be attached improperly which means that the product is too fragile for normal conditions of use. The unit i purchased arrived with visibly broken wires, yet was still able to power on and be partially functional. As these electronics are housed in a metal enclosure, there is a high potential for receiving a shock, though fortunately i suffered no injury. Incident date: (b)(6) 2012, this is an estimate. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025585 |
| MDR Report Key | 2597370 |
| Date Received | 2012-05-30 |
| Date of Report | 2012-05-17 |
| Date of Event | 2012-04-26 |
| Date Added to Maude | 2012-06-05 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | BIOLOGICAL INCUBATOR |
| Product Code | JTQ |
| Date Received | 2012-05-30 |
| Model Number | TC-CW |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSCIENCE TOOLS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-30 |