MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-21 for SHIELDING INTERNATIONAL manufactured by .
[747639]
It was called to report that, the suspect product has been tested, and showed it is not only toxick, but also can kill the pt. The level of lead was reported at 66. 76 micro grams. No pt was involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004720 |
| MDR Report Key | 967842 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-01-21 |
| Date Added to Maude | 2007-12-31 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHIELDING INTERNATIONAL |
| Generic Name | LEAD BLANKET |
| Product Code | EAJ |
| Date Received | 2007-12-21 |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 939296 |
| Manufacturer Address | NORTHWEST EARL STREET P.O BOX Z186 MADRAS OR 97741 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |