FDA Adverse Event
Injury
Summary report: N
OCL SPLINT
MDR report key: 333831
·
Received May 17, 2001
Report
- Report Number
- 1928508-2001-00001
- Event Type
- Injury
- Date Received
- May 17, 2001
- Date of Event
- July 12, 1996
- Report Date
- April 15, 2001
- Manufacturer
- M-PACT WORLDWIDE MGMT CORP
- Product Code
- FYH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
POST LEFT FOREARM NONDISPLACED TORUS FRACTURE TO THE DISTAL RADIAL SHAFT, PT WAS REPORTED TO BE SPLINTED WITH AN OCL SUGAR TONG SPLINT. ON NEXT EXAMINATION REPORT IN 1996, TWO HEALING PARTIAL THICKNESS BURN AREAS ON THE DORSAL VOLAR FOREARM WERE NOTED, DORSAL AS MODERATE DEPTH, AND VOLAR AS 2ND DEGREE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23210 | OCL SPLINT | PLASTER SPLINTING | FYH | M-PACT WORLDWIDE MGMT CORP | NOT REPORTED | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 MO | Disability | ACE BANDAGE WRAP (07/12/1996 TO UNK). |