MAUDE Adverse Event Report: MEDLINE INDUSTRUIES MEDLINE XL PATIENT SOCK; STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Model Number MDTDBLTREADXL

Device Problems Device Slipped (1584); Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); Pain (1994); Hip Fracture (2349)

Event Date 07/26/2022

Event Type  Injury  

Event Description

Patient fell stating "i was trying to move the table" found on floor, supine, provider at bedside.Patient with complains of l hip pain.Provider to order x-ray.Patient broke his and required operating room.Later disclosed her patient socks were slippery.Patient is small and wearing an xl size sock.Socks available on unit for retrieval.Manufacturer response for socks, medline xl patient sock (per site reporter).No information on response or outcome of evaluation.

• Brand Name: MEDLINE XL PATIENT SOCK
• Type of Device: STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
• Manufacturer (Section D): MEDLINE INDUSTRUIES; one medline place; mundelein IL 60060
• MDR Report Key: 15248848
• MDR Text Key: 298140834
• Report Number: 15248848
• Device Sequence Number: 1
• Product Code: FQL
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MDTDBLTREADXL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other