MAUDE Adverse Event Report: HALYARD HEALTH DUCKBILL SURGICAL MASK; ICP FACIAL PROTECTION PRODUCTS

Model Number	48220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Respiratory Distress (2045)
Date of Event	07/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 1-nov-17 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.(b)(4).Device not returned.
Event or Problem Description
It was reported that following use of the mask, the user experienced redness, itching, and swollen lips and was treated with benadryl, steroid cream, and ventolin inhaler.Additional information has been requested but not yet provided.

• Brand Name: DUCKBILL SURGICAL MASK
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7001542
• Report Number: 9616096-2017-00002
• Device Sequence Number: 19170889
• Product Code: FXX
• UDI-Device Identifier: 30680651482205
• UDI-Public: 30680651482205
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2017

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: Physician
• Device Model Number: 48220
• Device Catalogue Number: 991048220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/03/2017
• Patient Sequence Number: 1