COMMODE ELEVATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-04-16 for COMMODE ELEVATOR manufactured by Pcp Champion Company.

Event Text Entries

[810] On or about 2/4/92 a patient at our hopewell health center in sumter, sc, was placed on a commode elevator. Apparently the patient leaned forward and the front leg of the elevator gave way. The patient fell to the floor and sustained a fractured hip. The patient was subsequently operated on to repair the hip. At this time the ability of the patient to fully recover has not been determined but some impairment is likelydevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 409
• MDR Report Key: 409
• Date Received: 1992-04-16
• Date of Report: 1992-03-31
• Date of Event: 1992-02-04
• Report Date: 1992-03-31
• Date Reported to FDA: 1992-03-31
• Date Added to Maude: 1992-04-23
• 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: COMMODE ELEVATOR
• Product Code: HDP
• Date Received: 1992-04-16
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 403
• Manufacturer: PCP CHAMPION COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-04-16