MAUDE Adverse Event Report: TIDI PRODUCTS POSEY; RESTRAINT, PROTECTIVE

Lot Number 0302T394

Device Problems Inadequacy of Device Shape and/or Size (1583); Defective Component (2292); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

The posey restraint is easily removed/unclamped by the patient.The straps are very thin.

Event Description

The posey restraint is easily removed/unclamped by the patient.The straps are very thin.

• Brand Name: POSEY
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 11421299
• MDR Text Key: 234927537
• Report Number: 11421299
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0302T394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Date Report to Manufacturer: 03/05/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21830 DA