MAUDE Adverse Event Report: OWENS & MINOR HALYARD FLUIDSHIELD* PORTED N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK; ICP FACIAL PROTECTION PRODUCTS

Model Number	46727
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product sample is not available for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 04may2020 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 o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.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).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 halyard health product is defective or caused serious injury.Other text : device not returned.
Event or Problem Description
It was reported by the customer who stated that she experienced a skin rash on her face after wearing the mask for a 12 hour period.She was seen by employee health in the emergency room and had a telemedicine consult with a physician as a follow up.The customer stated she was prescribed a topical steroid cream.The issue was resolved by switching to a different mask.The customer states that she has a history of existing allergies and carries an epipen.The customer stated she experienced shortness of breath wearing "a mask" but she states she is unsure if the sob occurred with a halyard mask.No additional information was provided.
Additional Manufacturer Narrative
The actual complaint product sample was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of (b)(6)2020 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 o&m halyard, inc.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 o&m halyard, inc.O&m halyard, inc.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).This information is submitted pursuant to (b)(4), in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): OWENS & MINOR HALYARD; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10024218
• Report Number: 9616096-2020-00004
• Device Sequence Number: 14079087
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K974068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2020

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: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other