FDA Adverse Event
Injury
Summary report: N
DELTA-SPLINT SYNTH RL 4" X 15FT
MDR report key: 490745
·
Received October 22, 2003
Report
- Report Number
- 1818910-2003-00709
- Event Type
- Injury
- Date Received
- October 22, 2003
- Report Date
- September 25, 2003
- Manufacturer
- DEPUY ORTHO TECH- NORTH BRUNSWICK J&J CO.
- Product Code
- FYH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER 5 DAYS OF USE IT STARTED TO STINK. THE PT HAD MACERATIONS AND BLISTERS ON SKIN. WHEN THE SPLINT WAS REMOVED THERE WERE SPOTS ON THE SPLINT AND THE PT'S SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA-SPLINT SYNTH RL 4" X 15FT | SOFT GOODS | FYH | DEPUY ORTHO TECH- NORTH BRUNSWICK J&J CO. | NA | 3106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |