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); Laceration(s) (1946)
Date of Event	10/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that while transferring the patient from her bed to a chair, a strap on the mesh sling broke.The patient experienced a fall onto the floor.Following the fall incident, the patient was taken to the emergency department (ed) for evaluation.The patient was diagnosed with an unspecified clavicle fracture and she required sixteen (16) staples for a laceration that she experienced to her head.No diagnostic exams or results were reported to the manufacturer.No additional medical treatment or impact to the patient's plan of care was reported to the manufacturer.No lot/serial number was able to be provided to the manufacturer as the reporting facility indicated that the tag on the mesh sling was no longer legible.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported clavicle fracture, head laceration, and need for medical intervention, 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 a mesh sling strap broke and the patient experienced a fall.

• Common Device Name: SLING,MESH,FULL BODY,COMMODE,LARGE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9306801
• Report Number: 1417592-2019-00186
• Device Sequence Number: 19365881
• Product Code: FSA
• UDI-Device Identifier: 10884389128763
• UDI-Public: 10884389128763
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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: Health Professional
• Device Catalogue Number: MDSMR115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/11/2019
• 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: Required Intervention; Disability
• Patient Age: 83 YR
• Patient Weight: 93