ST100 THERMAL THERAPY SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-29 for ST100 THERMAL THERAPY SYSTEM * manufactured by Burke Neutech.

Event Text Entries

[23414] "frostbite" due to continuous cold therapy to hand and forearm post-op plate and screw removal after bone healed from traumatic fracture approx 18 mos prior. Returned to hosp post-op day 5 with swollen arm and hand without circulation or sensation. Required emergent surgery to restore circulation. Had portable continuous cold therapy unit on hand for 48 hrs - 72 hrs post-op - in home setting. Question adequate product labeling and printed instructions for home use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 40838
• MDR Report Key: 40838
• Date Received: 1996-08-29
• Date of Report: 1996-08-28
• Date of Event: 1996-08-14
• Date Facility Aware: 1996-08-14
• Report Date: 1996-08-28
• Date Reported to FDA: 1996-08-28
• Date Reported to Mfgr: 1996-08-22
• Date Added to Maude: 1996-10-07
• 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
• Reporter Occupation: RISK MANAGER
• 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: ST100 THERMAL THERAPY SYSTEM
• Generic Name: PORTABLE COLD THERAPY DEVICE
• Product Code: IMF
• Date Received: 1996-08-29
• Model Number: ST100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 41926
• Manufacturer: BURKE NEUTECH
• Manufacturer Address: 1765 COMMERCE AVE ST PETERSBURG FL 33716 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	1996-08-29