MAUDE Adverse Event Report: CARDINAL HEALTH SHANGHAI SHOECOVER DURA FIT XL; COVER, SHOE, OPERATING-ROOM

Model Number	4854
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
Customer reported that an associate was wearing the dura fit shoe covers, slipped on a freshly mopped floor, and was seriously injured.Patient was admitted to the emergency department for broken bone.Associates have complained of no grip on the floor, that these are slippery, and then we had this incident.I also went back and put these on and slid across the floor.

• Brand Name: SHOECOVER DURA FIT XL
• Common Device Name: COVER, SHOE, OPERATING-ROOM
• Manufacturer (Section D): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai 20007 0; CH 200070
• Manufacturer (Section G): CARDINAL HEALTH SHANGHAI; f20, tower 1, kerry everbright; shanghai IL 20007 0; CH 200070
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21852862
• Report Number: 1423537-2025-00168
• Device Sequence Number: 20824064
• Product Code: FXP
• UDI-Device Identifier: 20885380019828
• UDI-Public: (01)20885380019828
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4854
• Device Catalogue Number: 4854
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/03/2025
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown