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

Catalog Number	MDSMR116
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the sling tore and the resident fell and broke their leg.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has not been returned to the manufacturer for evaluation.Due to the reported incident and in an abundance of caution, 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 the sling tore and the resident fell and broke their leg.

• Common Device Name: SLING,MESH,FULL BODY,COMMODE,XL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10614538
• Report Number: 1417592-2020-00112
• Device Sequence Number: 1281981
• Product Code: FSA
• UDI-Device Identifier: 10884389128770
• UDI-Public: 10884389128770
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: MDSMR116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 10/01/2020
• 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