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 |