MAUDE Adverse Event Report: LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD SHOECOVER ANTI-SKID; COVER, SHOE, OPERATING-ROOM

Model Number	2854
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample for evaluation has been shipped to the manufacturer.The evaluation is still ongoing.A followup mdr will be filed when the evaluation is completed.
Event or Problem Description
A staff member fell and was injured while wearing the shoe covers.They believe it is because of the shoe covers not having any tread on them.
Additional Manufacturer Narrative
Based on the supplier investigation, the device history record review did not indicate any exception that could lead to the reported incident.According to the supplier this is the first slippery issue in the past 12 months.The raw materials used on the product are provided by approved suppliers, consistent to the bill of material, passed incoming inspection, and they have not changed their manufacturing/storing/transferring processes on this product.From the process review, the shoe cover glue machines are normal, within calibration expiration date, and all have daily checks, weekly checks and monthly maintenance.The products are glued with validated parameters and produced a in normal manufacturing environment.Tests conducted during production showed the measured cof (coefficient of friction) factor to be meeting the specification.Two pieces of samples were returned for investigation.The anti-slip strips on shoe covers are complete and clearly visible.The width of the glue meets the requirement.The sewing line was located in the middle of the sole and the anti-skid was evenly distributed on both sides.From the investigation, the root cause could not be determined.The supplier will continue to monitor their manufacturing process, including manufacturing environment and equipment.They will monitor the trend for this type of issue.

• Brand Name: SHOECOVER ANTI-SKID
• Common Device Name: COVER, SHOE, OPERATING-ROOM
• Manufacturer (Section D): LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD; no. 9 hongkong rd.; ganyu economic development zon; lianyungang jiangsu 22200 0; CH 222000
• MDR Report Key: 8452503
• Report Number: 1423537-2019-00295
• Device Sequence Number: 2639811
• Product Code: FXP
• UDI-Device Identifier: 20885380018357
• UDI-Public: 20885380018357
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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?: No
• Operator of Device: No Information
• Device Model Number: 2854
• Device Catalogue Number: 2854
• Device Lot Number: 18HDFNA046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Distributor Facility Aware Date: 02/26/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization