FDA Adverse Event
Injury
Summary report: N
OCL SUGAR TONG SPLINT
MDR report key: 36073
·
Received August 20, 1996
Report
- Report Number
- 36073
- Event Type
- Injury
- Date Received
- August 20, 1996
- Date of Event
- July 22, 1996
- Report Date
- July 29, 1996
- Manufacturer
- M-PACT
- Product Code
- FYH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
PT CAME TO EMERGENCY DEPARTMENT ON 7/12/96 AND WAS DIAGNOSED WITH A DISTAL RADIUS FRACTURE. AND SPLINT WAS APPLIED. ON 7/22/96 THE PT RETURNED TO THE ED WITH A HEALING PARTIAL THICKNESS BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OCL SUGAR TONG SPLINT | SPLINT | FYH | M-PACT | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 MO | Required Intervention |