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

Model Number MDT821301QL

Device Problem Break (1069)

Patient Problem Irritability (2421)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

Restraint on intubated, agitated patient tightened, clip on restraint broke therefore releasing restraint.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15797010
• MDR Text Key: 303635541
• Report Number: 15797010
• 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: 11/07/2022

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: 84321120037
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic