MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. QUICK RELEASE LIMB HOLDER; RESTRAINT, PROTECTIVE

Catalog Number MDT829090WQ

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

This violent patient broke through his restraints, stood on the stretcher and began pulling on the glass surrounding the nurse¿s station.The stitching on the restraint came undone.

Event Description

This violent patient broke through his restraints, stood on the stretcher and began pulling on the glass surrounding the nurse¿s station.The stitching on the restraint came undone.

• Brand Name: QUICK RELEASE LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13422727
• MDR Text Key: 284896419
• Report Number: 13422727
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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 Catalogue Number: MDT829090WQ
• Device Lot Number: 84321020001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Sex: Male
• Patient Weight: 100 KG