POSEY SLEEVED JACKET RESTRAINT 3350

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-09-15 for POSEY SLEEVED JACKET RESTRAINT 3350 manufactured by J.t. Posey, Co..

Event Text Entries

[689] Patient discovered hanging over bedside rail with posey restraint still on. One restraint strap loose. Hanging with head about one to two incches from floor. Blood was restraint at neck line, and around mouth was found at 5:45 a. M. By cna. Was sent to medical center for evaluation. Died in hospital several hours later. State surveyor reported on his hospital record 1. Possible multiple internal injuries. 2. Shock, probably secondary to restraint. 3. Cardiac arrestinvalid data - regarding single use labeling of device. Patient medical status prior to event: satisfactory 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 not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided, inserviced by manufacturer/distributor representative. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1356
• MDR Report Key: 1356
• Date Received: 1992-09-15
• Date of Report: 1992-09-04
• Date of Event: 1992-08-24
• Date Facility Aware: 1992-08-24
• Report Date: 1992-09-04
• Date Reported to FDA: 1992-09-04
• Date Reported to Mfgr: 1992-09-03
• Date Added to Maude: 1992-09-23
• 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: POSEY SLEEVED JACKET RESTRAINT
• Product Code: BRT
• Date Received: 1992-09-15
• Model Number: 3350
• Lot Number: 059
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1300
• Manufacturer: J.T. POSEY, CO.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-09-15