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).