MAUDE Adverse Event Report: HALYARD HEALTH PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW; ICP FACIAL PROTECTION PRODUCTS

Model Number	47117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Distress (2045); Reaction (2414)
Date of Event	01/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product has been returned and is being processed.The device history record for the lot number, am7237091, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of (b)(6) 2018 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, a staff member experienced an anaphylactic reaction while wearing the mask.The patient was sent to the emergency room for treatment.Additional information was received on (b)(6) 2018 from the distributor that states, "last week they had an employee that had a reaction to the mask".Additional information was received (b)(6) 2018 from the hr generalist that stated, the individual reported that her, ¿throat started closing up¿ and she went to the ed (emergency department) for treatment.The event involved respiratory distress and medical intervention.No further information was provided.Additional information was received on (b)(6) 2018 by email that stated,"i had been wearing the mask since i arrived at 12:00 pm.Yes, i had been wearing the mask for a couple of weeks.There have been no known allergies, and have not taken medications for allergies.When i was in the emergency room they gave me a steroid treatment; however, i'm not sure what the name of the medication was.The reaction was resolved by discontinuing wearing the mask, and taking the steroids prescribed by the emergency room doctor, and wearing a different mask.I have not had another reaction." no additional information has been received.
Additional Manufacturer Narrative
The sample was returned for evaluation.One opened box of samples were received.The total number of samples received in the box is 35.The original total count for an unopened box is 50.The samples were evaluated under ambient light conditions.A 100% inspection was performed on the masks.The masks were removed from the box and inspected for any visual damage.No visual damage was observed on any masks.The masks were compared to specification component drawing.The masks were found to be assembled according to the specification drawing.The dimensions of ten (10) masks were measured using a certified ruler; (tqa030 calibrated on 11 feb 2017, next calibration due 28 feb 2019) two (2) measured masks are recorded.The measurements were found to be as stated in the specification drawing.Unable to confirm the failure reported at this time; therefore, a root cause could not be determined.All information reasonably known as of 22jan2018 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).

• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7226556
• Report Number: 9616096-2018-00001
• Device Sequence Number: 11008914
• Product Code: FXX
• UDI-Device Identifier: 30680651471179
• UDI-Public: 30680651471179
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 08/25/2022
• Device Model Number: 47117
• Device Catalogue Number: 991047117
• Device Lot Number: AM7237091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 02/23/2018
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 73