MAUDE Adverse Event Report: E.M. ADAMS, INC. E.M ADAMS CO, INC.; RESTRAINT, PROTECTIVE

Model Number 26-0647-1

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Irritation (1941)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

Patient was restrained to the bed frame, and started to become agitated when he raised his arms and the restraint limb holder cuff tore from the nylon strap.

• Brand Name: E.M ADAMS CO, INC.
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): E.M. ADAMS, INC.; 7496 commercial circle; fort pierce FL 34951
• MDR Report Key: 11055183
• MDR Text Key: 241252751
• Report Number: 11055183
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2020,11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 26-0647-1
• Device Lot Number: HN 09-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2020
• Date Report to Manufacturer: 12/22/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1