FDA Adverse Event
Other
Summary report: N
DEROYAL
MDR report key: 261595
·
Received February 4, 2000
Report
- Report Number
- 1624487-2000-00001
- Event Type
- Other
- Date Received
- February 4, 2000
- Date of Event
- January 4, 2000
- Report Date
- February 2, 2000
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- LGF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
AFTER SPLINTING MATERIAL WAS APPLIED TO THE PT'S POSTERIOR RIGHT LEG, PT COMPLAINED OF DISCOMFORT. THE MATERIAL WAS REMOVED, AND THE SKIN WAS NOTED TO BE RED IN COLOR. THE PT WAS TREATED FOR A FIRST DEGREE BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEROYAL | UNIVERSAL SPLINTING SYSTEM | LGF | DEROYAL INDUSTRIES, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |