CENTURY SAF-KARY SK-10 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-19 for CENTURY SAF-KARY SK-10 N/A manufactured by Century Mfg. Co..

Event Text Entries

[14401] Nursing assistant was transporting resident to tub via tub chair with safety belt applied. Frame of chair broke and seat of chair fell to floor. Resident struck left knee on floor and right shoulder on wall. Sustained ecchymotic area and superficial abrasion to left knee. Area cleansed and ice applied. Right shoulder and left knee were x-rayed on 5/5/94 and both x-rays negative. Upon inspection of chair rust was identified on frame where frame broke. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-94. Service provided by: other. Service records not 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: component failure, material degradation/deterioration, component failure. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 25898
• MDR Report Key: 25898
• Date Received: 1995-01-19
• Date of Report: 1995-01-02
• Date of Event: 1994-05-05
• Date Facility Aware: 1994-05-05
• Report Date: 1995-01-02
• Date Reported to Mfgr: 1994-05-13
• Date Added to Maude: 1995-09-20
• 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: CENTURY SAF-KARY
• Generic Name: N/A
• Product Code: IQB
• Date Received: 1995-01-19
• Model Number: SK-10
• Catalog Number: N/A
• ID Number: PAT 3270353
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 26556
• Manufacturer: CENTURY MFG. CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1995-01-19