MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-02 for JUMBO CLEAR PB MOBILE X-RAY BARRIER manufactured by Radmart Corporation.
[20438770]
Screen received 6/94. Notified on 5/1/95 of product recall because screen did not contain lead. Screen removed from service. Equipment incident reported to pt relations department on 7/25/95. Pt relations department followed-up with distributor who has made a med watch report. Physician and employees used screen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 30874 |
| MDR Report Key | 30874 |
| Date Received | 1996-02-02 |
| Date of Report | 1995-08-16 |
| Date of Event | 1995-05-01 |
| Date Facility Aware | 1995-05-01 |
| Report Date | 1995-08-17 |
| Date Added to Maude | 1996-03-08 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JUMBO CLEAR PB MOBILE X-RAY BARRIER |
| Generic Name | JUMBO CLEAR PB MOBILE X-RAY BARRIER |
| Product Code | IWX |
| Date Received | 1996-02-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31929 |
| Manufacturer | RADMART CORPORATION |
| Manufacturer Address | 5126 CLARETON ST STE 120 AGOURA HILLS CA 91301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-02-02 |