PERSONAL BODY HOLDER N/A 24451-020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-29 for PERSONAL BODY HOLDER N/A 24451-020 manufactured by Technol, Inc..

Event Text Entries

[21587525] Patient found sitting on the floor between the siderails of his bed with the vest restraint on and tied to the bedframe. Vest restraint pressing on patient's throat causing cyanosis. Blue tie of the restraint tied and stretched across patient's throat. Restraint removed, patient assisted to bed. Patient monitored and oxygen administered. Vest restraint was used according to packaging directions. Event is an inherent risk of using restraints. There was no device failure. Device not labeled for single use. Patient medical status prior to event: fair condition. 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: a device from same lot was evaluated, performance tests performed, visual examination. Results of evaluation: telemetry failure, other, inherent risk of procedure. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: inserviced by manufacturer/distributor representative, other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4301
• MDR Report Key: 4301
• Date Received: 1992-06-29
• Date of Report: 1992-06-29
• Date of Event: 1991-12-13
• Date Facility Aware: 1991-12-13
• Report Date: 1992-06-29
• Date Reported to Mfgr: 1991-12-23
• Date Added to Maude: 1993-05-20
• 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: PERSONAL BODY HOLDER
• Generic Name: VEST RESTRAINT
• Product Code: BRT
• Date Received: 1992-06-29
• Model Number: N/A
• Catalog Number: 24451-020
• Lot Number: N/A
• ID Number: U.S.PATENT NO. 275,230
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4027
• Manufacturer: TECHNOL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-06-29