FDA Adverse Event
Summary report: N
TUNGSTEN
MDR report key: 3052062
·
Received March 29, 2013
Report
- Report Number
- 3052062
- Date Received
- March 29, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 28, 2013
- Manufacturer
- RADIATION PRODUCT DESIGN, INC.
- Product Code
- IWS
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PATIENT WITH MYCOSIS FUNGOIDES LYMPHOMA AND RIGHT EYE ECTROPIAN, HAD BILATERAL TUNGSTEN 3MM SHIELDS PLACED IN HIS EYES TO PROTECT HIS EYES FROM RADIATION TREATMENT. TOBRADEX OINTMENT WAS PLACED IN BOTH SHIELDS PRIOR TO INSERTION IN THE EYES. THE PATIENT SUSTAINED A RIGHT EYE CORNEAL ABRASION (LEFT EYE WAS FINE). AFTER THE FACT, THE STAFF EXAMINED THE SHIELD AND NOTED THAT THE SHIELD TO THE RIGHT EYE MIGHT NOT HAVE BEEN SMOOTH. THEY WERE ABLE TO FEEL, BUT NOT SEE A NICK IN THE SHIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RADIATION TO EYE LIDS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129643 | TUNGSTEN | SHIELD, EYE, RADIOLOGICAL | IWS | RADIATION PRODUCT DESIGN, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |