MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-29 for EZEM; PICKER ULTIMA * 265504 manufactured by E-z-e-m, Inc..
[20527240]
Lead protective clothing has apparent inherent radioactive materials present. The probable radioactive contaminants include pb-210, bi-210, po-210.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011789 |
| MDR Report Key | 109472 |
| Date Received | 1997-07-29 |
| Date Added to Maude | 1997-08-01 |
| 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 |
| Reporter Occupation | PHYSICIST |
| 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 | EZEM; PICKER ULTIMA |
| Generic Name | LEADED GARMENTS |
| Product Code | KPY |
| Date Received | 1997-07-29 |
| Returned To Mfg | 1997-07-14 |
| Model Number | * |
| Catalog Number | 265504 |
| Lot Number | 127 |
| ID Number | CUSTOM CUTS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 107600 |
| Manufacturer | E-Z-E-M, INC. |
| Manufacturer Address | 717 MAIN ST. WESTBURY NY 115905021 US |
| Brand Name | EZEM; PICKER ULTIMA |
| Generic Name | LEADED GARMENTS |
| Product Code | KPY |
| Date Received | 1997-07-29 |
| Returned To Mfg | 1997-07-14 |
| Model Number | * |
| Catalog Number | 264643 |
| Lot Number | NOT LISTED |
| ID Number | CUSTOM CUTS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 2 |
| Device Event Key | 107601 |
| Manufacturer | E-Z-E-M, INC. |
| Manufacturer Address | 717 MAIN ST. WESTBURY NY 115905021 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-07-29 |