MAUDE Adverse Event Report: LIANYUNGANG ANSON SHOECOVER DURA FIT XL ANTI-SKID; COVER, SHOE, OPERATING-ROOM

Model Number	4854
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Concussion (2192)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently in progress.A follow-up report will be filed once the results have been completed.
Event or Problem Description
The customer reported, "on this morning¿s system huddle, a team member fall with injury was reported with the culprit being shoe covers without non-skid bottoms.Floor had been cleaned and was safe if wearing normal shoes, but was ¿slick as glass¿ according to dr.Ochsenbein with the shoe covers".The team member hit her head from the fall which caused a concussion.She was treated in the emergency room and scanned for further injuries.Event date is unknown.
Additional Manufacturer Narrative
The device history record could not be reviewed as no lot information was provided within the complaint.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 issue.The root cause could not be determined for this case.We will continue to monitor and take actions as applicable.

• Brand Name: SHOECOVER DURA FIT XL ANTI-SKID
• Common Device Name: COVER, SHOE, OPERATING-ROOM
• Manufacturer (Section D): LIANYUNGANG ANSON; no. 9, hongkong rd; jiangsu province; liangyungang city 22200 0; CH 222000
• Manufacturer (Section G): LIANYUNGANG ANSON; no. 9, hongkong rd; jiangsu province; liangyungang city IL 22200 0; CH 222000
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 23514725
• Report Number: 1423537-2025-00455
• Device Sequence Number: 9667272
• Product Code: FXP
• UDI-Device Identifier: 20192253061755
• UDI-Public: (01)20192253061755
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 11/17/2025
• Report Date (Section F): 10/27/2025

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/21/2025
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown