MAUDE Adverse Event Report: O&M HALYARD, INC. LITE ONE SURGICAL MASK BLUE, 50; ICP FACIAL PROTECTION PRODUCTS

Model Number	28802
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Inflammation (1932); Reaction (2414)
Date of Event	01/10/2019
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 06feb2019 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 o&m halyard, inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that following the use of a mask, a doctor had an allergic reaction.The doctor developed swollen lips and tongue and needed treatment, which included steroid injection.The doctor was informed his symptoms were due to an allergic response.Additional information was received on 15-jan-2019 from the doctor that stated, all ok.No additional information was provided.
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 06march2019 has been included in this health authority report.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 o&m halyard, inc.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 o&m halyard, inc.Product is defective or caused serious injury.
Event or Problem Description
It was reported that following the use of a mask, a doctor had an allergic reaction.The doctor developed swollen lips and tongue and needed treatment, which included steriod injection.The doctor was informed his symptoms were due to an allergic response.Additional information was received on 15-jan-2019 from the doctor that stated, all ok.No additional information was provided.As of 06march2019 no additional information received.

• Brand Name: LITE ONE SURGICAL MASK BLUE, 50
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8311908
• Report Number: 9616096-2019-00001
• Device Sequence Number: 16736921
• Product Code: FXX
• UDI-Device Identifier: 30680651288029
• UDI-Public: 30680651288029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: D321003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019

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: No Information
• Device Model Number: 28802
• Device Catalogue Number: 991028802
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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