CASE IV 5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-04-29 for CASE IV 5000 manufactured by Wr Medical Electronics Co..

Event Text Entries

[59824] While using the devices heat pain analog visual scale (hpavs) test a patient was given the maximum stimulation jnd 25 which caused a 3rd degree burn the size of a dime on the dorsum of his left foot. The patient had been previously tested insensitive using other. Same device test.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2118418-1997-00001
• MDR Report Key: 87225
• Report Source: 05
• Date Received: 1997-04-29
• Date of Report: 1997-04-29
• Date of Event: 1997-03-31
• Date Mfgr Received: 1997-04-07
• Date Added to Maude: 1997-04-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CASE IV
• Generic Name: COMPUTER AIDED SENSORY EVALUATOR
• Product Code: LLN
• Date Received: 1997-04-29
• Model Number: IV
• Catalog Number: 5000
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 86392
• Manufacturer: WR MEDICAL ELECTRONICS CO.
• Manufacturer Address: 123 N. 2ND STREET STILLWATER MN 55082 US
• Baseline Brand Name: CASE IV
• Baseline Generic Name: NA
• Baseline Model No: IV
• Baseline Catalog No: 5000
• Baseline ID: NA
• Baseline Device Family: NEUROPATHY PRODUCT
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K910624
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-04-29