POSEY SAFETY BELT 4127

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-11 for POSEY SAFETY BELT 4127 manufactured by Posey Co..

Event Text Entries

[4712] Resident was left sitting in wheelchair with belt on. Resident was found kneeling in front of wheelchair. Teeth were missing from roller on belt buckle. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not 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. 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, design - inadequate. Conclusion: device failure occurred and was related to event, device failure directly caused event, device failure directly contributed to 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: 8189
• MDR Report Key: 8189
• Date Received: 1993-08-11
• Date of Report: 1993-06-14
• Date of Event: 1993-05-07
• Date Facility Aware: 1993-05-07
• Report Date: 1993-06-14
• Date Reported to FDA: 1993-06-14
• Date Reported to Mfgr: 1993-06-14
• Date Added to Maude: 1994-07-27
• 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: POSEY SAFETY BELT
• Generic Name: PHYSICAL SAFETY BELT
• Product Code: IQB
• Date Received: 1993-08-11
• Model Number: NA
• Catalog Number: 4127
• Lot Number: NA
• ID Number: NA
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7864
• Manufacturer: POSEY CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-11