MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-25 for LEAD APRON * manufactured by Lite-tech, Inc..
[57979]
Physicist checked devices because of a report he saw on internet. Background reading is. 02 mr per hour. Each of the protective devices he checked measured well over background from 0. 5 to 2. 0 mr per hour. He reports no urgency in removing devices from dept. Devices included: 3 lead aprons; 1 lap apron and 4 thyroid shields.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1011560 |
MDR Report Key | 100374 |
Date Received | 1997-06-25 |
Date of Report | 1997-06-25 |
Date of Event | 1997-06-17 |
Date Added to Maude | 1997-06-26 |
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 | 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 | LEAD APRON |
Generic Name | LEAD APRON |
Product Code | EAJ |
Date Received | 1997-06-25 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | STYLE 610A-K |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 98887 |
Manufacturer | LITE-TECH, INC. |
Manufacturer Address | 2ND & DEPOT ST. BRIDGEPORT PA 19405 US |
Brand Name | LEAD APRON |
Generic Name | LEAD APRON |
Product Code | EAJ |
Date Received | 1997-06-25 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | STYLE 610A-A |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 2 |
Device Event Key | 98890 |
Manufacturer | LITE-TECH, INC. |
Manufacturer Address | 2ND & DEPOT ST. BRIDGEPORT PA 19405 US |
Brand Name | LEAD APRON |
Generic Name | LEAD APRON |
Product Code | EAJ |
Date Received | 1997-06-25 |
Model Number | * |
Catalog Number | * |
Lot Number | * |
ID Number | 610A-E |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 3 |
Device Event Key | 98893 |
Manufacturer | LITE-TECH, INC. |
Manufacturer Address | 2ND & DEPOT ST BRIDGEPORT PA 19405 US |
Brand Name | LAP APRON |
Generic Name | LAP APRON |
Product Code | IWO |
Date Received | 1997-06-25 |
Model Number | * |
Catalog Number | 640H-3 |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 4 |
Device Event Key | 98894 |
Manufacturer | LITE-TECH, INC. |
Manufacturer Address | 2ND & DEPOT ST. BRIDGEPORT PA 19405 US |
Brand Name | THYROID SHIELD |
Generic Name | THYROID SHIELD |
Product Code | KPY |
Date Received | 1997-06-25 |
Model Number | * |
Catalog Number | 640T |
Lot Number | * |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 5 |
Device Event Key | 98896 |
Manufacturer | LITE-TECH, INC. |
Manufacturer Address | 2ND & DEPOT ST. BRIDGEPORT PA 19405 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1997-06-25 |