MAUDE Adverse Event Report: HALYARD HEALTH NOVAPLUS SHOE COVER EXTRA TRACTION XLG 80; X-TRA TRACTION* SHOE COVER, XL, BLUE

Model Number	69195
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of (b)(6) 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported by the customer who stated, "there has been a major employee injury here at the hospital within the last few days." the was no traction at the bottom of the show cover and the employee slipped.Additional information has been requested by not received.
Additional Manufacturer Narrative
A sample or lot number was not received for the affected product; however, based on the manufacturing history, there is no lot number ca716004 as reported that was produced for product 69195, the device history records can not be traced for this lot number.A root cause cannot be determined at this time.All information reasonably known as of 24jan2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: NOVAPLUS SHOE COVER EXTRA TRACTION XLG 80
• Common Device Name: X-TRA TRACTION* SHOE COVER, XL, BLUE
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7141510
• Report Number: 3011270181-2017-00010
• Device Sequence Number: 19086293
• Product Code: LYU
• UDI-Device Identifier: 30680651691959
• UDI-Public: 30680651691959
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: Other Health Care Professional
• Device Model Number: 69195
• Device Catalogue Number: 991069195
• Device Lot Number: CA716004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 01/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other