MAUDE Adverse Event Report: O&M HALYARD, INC. XTRA TRAC SHOEC, XLG; APPAREL HEADWEAR/FOOTWEAR

Model Number	69254
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
The grip tape on the bottom of the covers is smooth and not tacky.Staff member slipped on a textured ramp while wearing these covers and was injured.Additional details regarding injury were requested on august 18 and august 23, 2023.No response has been received to-date.
Additional Manufacturer Narrative
A follow-up report will be provided upon conclusion of the investigation.A scar was issued to hubei xinxin non-woven co., ltd the manufacturer of the xtra trac shoec, xlg product code 69254 on august 21, 2023.Hubel xinxin non-woven co., ltd (fda registration 3011547453).This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.H3 other text : device not returned.
Additional Manufacturer Narrative
Sample from customer was received on (b)(6) 2023.There is only one shoe cover in the box.It is a random representative sample provided by the customer and it is not certain that it¿s the same batch as the complaint lot.We observed the printed pattern on the bottom of the shoe cover, and there was no abnormality.The sample was returned to the manufacturer (hubei xinxin non-woven co) for evaluation.The average static friction is (b)(4) and the average kinetic friction is (b)(4).The results meet the requirements of specification.Contract manufacturer responded to supplier corrective action request with the following findings on september 28, 2023.Lot number was not provided.We have reviewed the inspection records of this product 69254 from august 2022 to august 2023, and found no problems similar to the complaint.The last three batches of fabric inspection records were reviewed and passed.Two batches of 69254 were in the warehouse and evaluated.Their results meet the specification.A root cause was not determined.The customer was asked about specific details of the complaint, such as the environment during use and there was no feedback provided.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or has caused serious injury.
Event or Problem Description
The site reached out to the complaint reporter for additional incident details on august 18, august 22, and august 23.The customer has not responded to requests for additional details to support investigation.

• Brand Name: XTRA TRAC SHOEC, XLG
• Common Device Name: APPAREL HEADWEAR/FOOTWEAR
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): HUBEI XINXIN NON-WOVEN CO., LTD; taizihu industrial park; pengchang town; xiantao huber, cn 43301 8; CH 433018
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17743922
• Report Number: 3014421917-2023-00013
• Device Sequence Number: 4085680
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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: 69254
• Device Catalogue Number: 991069254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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