POSEY SHOULD VEST 3705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-06 for POSEY SHOULD VEST 3705 manufactured by Posey Company.

Event Text Entries

[20520182] Resident was sliding out of her wheelchair. S-vest restraint was tight against her neck. Resident;s face and hands were purple. The restraint had to be cut to remove it from the resident. The restraint was applied incorrectly and the resident was in a rayon fabric hoyer sling which contributed to her sliding down in the wheelchair. The prevent reoccurrence, staff was inserviced re: correct application of the restratint. Additionally, a non-skid pad will be utilized in the wheelchair and mesh fabric hoyer sling to prenent slipping. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: invalid data. Service records not available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, none or unknown, other, misapplication of device. Conclusion: device discarded - unable to follow-up, there was no device failure, user error caused event, none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device discarded, inserviced by other facility staff. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4358
• MDR Report Key: 4358
• Date Received: 1992-07-06
• Date of Report: 1992-06-25
• Date of Event: 1992-04-19
• Date Facility Aware: 1992-04-19
• Report Date: 1992-06-25
• Date Reported to Mfgr: 1992-04-28
• Date Added to Maude: 1993-05-21
• 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 SHOULD VEST
• Generic Name: S-VEST RESTRAINT
• Product Code: KID
• Date Received: 1992-07-06
• Catalog Number: 3705
• Lot Number: H 169370514
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 4083
• Manufacturer: POSEY COMPANY

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-06