MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SLING,MESH,FULL BODY,COMMODE,LARGE

Catalog Number	MDSMR115
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	07/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while in use, the top right loop of the lift sling "broke" and the patient experienced a fall resulting in a vertebral fracture.Reportedly, two staff members placed the lift sling under the patient and attached the lift sling to the transfer unit.During transfer, the reported loop "broke" and the patient fell on to the floor.The patient was taken to the local emergency department for evaluation after the fall.An x-ray and a magnetic resonance imaging scan were performed which showed the patient experienced a fracture to the 5th cervical vertebra and a wedge compression fracture of thoracic vertebra.The patient was placed into a hard cervical collar and was reportedly admitted from (b)(6) 2017.The admitting diagnosis was not reported.The patient has reportedly required continuous use of a hard cervical collar and follow up with a neurosurgeon, rehab, and speech therapy since hospitalization.The facility is unable or unwilling to return the lift sling to the manufacturer for evaluation.The facility submitted photos of the lift sling for the manufacturer to review.The reported product issue was confirmed.A root cause cannot be determined without evaluation of a physical sample.Due to the reported incident and the need for hospitalization, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that while in use, the top right loop of the lift sling "broke" and the patient experienced a fall resulting in a vertebral fracture.

• Common Device Name: SLING,MESH,FULL BODY,COMMODE,LARGE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7328808
• Report Number: 1417592-2018-00011
• Device Sequence Number: 11191733
• Product Code: FSA
• UDI-Device Identifier: 10884389128763
• UDI-Public: 10884389128763
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Catalogue Number: MDSMR115
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 89 YR
• Patient Weight: 70