MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; RESTRAINT, PROTECTIVE

Model Number MDT821301QL

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

Patient transferred to 6 icu on restraints.When rn went to reapply restraints on icu bed, buckle of restraint did not click in.Manufacturer response for restraint, protective, medline (per site reporter) unknown.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15182397
• MDR Text Key: 297445705
• Report Number: 15182397
• 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
• Report Date: 08/02/2022

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 Model Number: MDT821301QL
• Device Catalogue Number: MDT821301QL
• Device Lot Number: 33022030001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1