MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE SLING; CHAIR, POSITIONING, ELECTRIC

Model Number MDSMMHS3

Device Problem Break (1069)

Patient Problems Death (1802); Fall (1848); Laceration(s) (1946); Fracture, Arm (2351)

Event Date 07/26/2019

Event Type  Death  

Event Description

My mother, (b)(6), was being transported via medline hoyer lift (model ds600el) using a medline hoyer sling (model# mdsmmhs3, lot: 52517050001) when four (4) of the six (6) straps broke.This led to my mom falling from 3 feet in the air causing multiple injuries, including head laceration, leg laceration, two arms laceration, 2 broken ribs, a broken elbow, and 3 broken vertebrae (2 cervical, 1 thoracic).Due to these injuries sustained, and as a direct result of the accident, my mother passed away on (b)(6) 2019.The (b)(6) coroner investigated the accident.Fda safety report id# (b)(4).

• Brand Name: MEDLINE SLING
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8964810
• MDR Text Key: 156732196
• Report Number: MW5089547
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/31/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDSMMHS3
• Device Lot Number: 52517050001
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 88 YR
• Patient Weight: 105