OCL SUGAR TONG SPLINT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-20 for OCL SUGAR TONG SPLINT * manufactured by M-pact.

Event Text Entries

[25684] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 36073
• MDR Report Key: 36073
• Date Received: 1996-08-20
• Date of Report: 1996-07-29
• Date of Event: 1996-07-22
• Date Facility Aware: 1996-07-22
• Report Date: 1996-07-29
• Date Reported to Mfgr: 1996-07-31
• Date Added to Maude: 1996-08-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OCL SUGAR TONG SPLINT
• Generic Name: SPLINT
• Product Code: FYH
• Date Received: 1996-08-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 37495
• Manufacturer: M-PACT
• Manufacturer Address: 1040 OCL PKWY EUDORA KS 66025 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-08-20