NONE KNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-26 for NONE KNOWN manufactured by Lafayette Orthodicts.

Event Text Entries

[170067] A compression device that was "thought up" by dr and made by orthotist was placed on pt for a post myelogram cat scan. Torque and applied weight of an estimated 40% of body weight was placed on the right side of pt's body, followed by the same on the left. Even though pt complained of the discomfort, the device was kept on throughout the procedure and was removed at the end due to pt's insistence because of the upper back and neck pain. Pt later found that this was a homemade device and the person placing this device was an orthotist, not a physical therapist as he had stated during the application. Dr refused to acknowledge any of the complaints of pain and unexpected/unexplained deficiencies in pt's health post this test. Pt did not sign any sort of release or informed consent for these persons to use this non-approved, experimental device. Pt was experiencing continued migraine headaches, blurred vision, weakness in bilateral upper extremities, loss in height of approx 1 1/2 to 2 inches, shortness of breath, apparent scoliosis and kyphosis, extreme fatigue and constant chronic pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020025
• MDR Report Key: 298289
• Date Received: 2000-09-26
• Date of Report: 2000-09-26
• Date of Event: 1998-01-28
• Date Added to Maude: 2000-10-02
• Event Key: 0
• Report Source Code: Voluntary 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: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NONE KNOWN
• Generic Name: AXIAL LOADING JACKET
• Product Code: IPT
• Date Received: 2000-09-26
• Model Number: NA
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 288737
• Manufacturer: LAFAYETTE ORTHODICTS
• Manufacturer Address: * LAFAYETTE LA * US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2000-09-26