MAUDE Adverse Event Report: O&M HALYARD, INC. FLUIDSHIELD* LEVEL 1 SURGICAL MASK WITH SO SOFT* LINING; ICP FACIAL PROTECTION PRODUCTS

Catalog Number	28800
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Asthma (1726)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product 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 12jul2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Event or Problem Description
On 01-may-2019 medwatch form fda 3500a notification user facility report number (b)(4).It was reported that seven respiratory therapists and a few nurses had adverse reactions to the halyard fluidshield masks.Some reactions resulted in asthma attacks one of which required an emergency room visit, while others resulted in a facial rash and hives.Reactions were so widespread and severe that we discontinued use of this particular product.No additional information was received.

• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8780958
• Report Number: 9616096-2019-00005
• Device Sequence Number: 1889685
• Product Code: FXX
• UDI-Device Identifier: 30680651288005
• UDI-Public: 30680651288005
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K000402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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 Catalogue Number: 28800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other