MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. HOYER SLING; LIFT PATIENT, NON AC POWERED

Lot Number 5251705001

Device Problems Break (1069); Material Separation (1562)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 07/26/2019

Event Type  Injury  

Event Description

Four of the 6 hoyer sling loops ripped from the body of the sling, during a transfer.Per investigation, all instructions related to maintenance and care provided by the mfr were being followed.The malfunction resulted in the pt falling from the hoyer sling sustaining multiple fractures and lacerations.

• Brand Name: HOYER SLING
• Type of Device: LIFT PATIENT, NON AC POWERED
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; winnetka IL 60093
• MDR Report Key: 8896609
• MDR Text Key: 154566512
• Report Number: MW5089060
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5251705001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 105