THE COMPANY IS OUT OF BUSINESS. IT IS A DONATED WHEELCHAIR.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for THE COMPANY IS OUT OF BUSINESS. IT IS A DONATED WHEELCHAIR. manufactured by Sheperd Medical Products.

Event Text Entries

[15378756] The patient was riding the wheelchair down the hallway when the ballbearing gave way and the left front small wheel fell off of the wheelchair. The wheelchair tipped forward and the patient fell out of the wheelchair. The patient hit her left arm on the floor. The patient suffered a left proximal humerus fracture. The patient was followed up by an appointment with a local orthopedic surgeon and a sling to immobilize the shoulder and arm. The company is out of business. The wheelchair was donateddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-nov-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: material degradation/deterioration. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6270
• MDR Report Key: 6270
• Date Received: 1993-08-16
• Date of Report: 1993-07-12
• Date of Event: 1993-07-12
• Date Facility Aware: 1993-07-12
• Report Date: 1993-07-12
• Date Reported to FDA: 1993-07-12
• Date Added to Maude: 1993-08-25
• 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: 0
• Initial Report to FDA: 0
• 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: THE COMPANY IS OUT OF BUSINESS. IT IS A DONATED WHEELCHAIR.
• Generic Name: IT IS A STANDARD WHEELCHAIR WITH DETACHABLE LEG REST AND IS
• Product Code: IMM
• Date Received: 1993-08-16
• Operator: OTHER CAREGIVERS
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5959
• Manufacturer: SHEPERD MEDICAL PRODUCTS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-08-16