FDA Adverse Event
Injury
Summary report: N
DELTA-LITE C-SPLINT 4 IN X 15 IN
MDR report key: 308287
·
Received December 13, 2000
Report
- Report Number
- 1818910-2000-00314
- Event Type
- Injury
- Date Received
- December 13, 2000
- Date of Event
- November 13, 2000
- Report Date
- December 13, 2000
- Manufacturer
- DEPUY-PURETO RICO/A DIVISION OF DEPUY ORTHOPAEDICS
- Product Code
- FYH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CLAIMS THAT THE PT RECEIVED 2ND DEGREE BURNS FROM THE PRODUCT. THE PADDING SIDE WAS TOWARD THE SKIN. THE PT IS BEING TREATED WITH ANTIBIOTIC LOTION FOR THE NEXT 1-2 WEEKS. PT COMPLAINED OF ITCHING; UPON REMOVAL OF THE SPLINT; FOUND THE ARM TO BE EXTREMELY RED AND SWOLLEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA-LITE C-SPLINT 4 IN X 15 IN | CASTING | FYH | DEPUY-PURETO RICO/A DIVISION OF DEPUY ORTHOPAEDICS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |