MAUDE Adverse Event Report: O&M HALYARD, INC. CHILD'S FACE MASK WITH SO SOFT* EARLOOPS (DISNEY); ICP FACIAL PROTECTION

Model Number	32856
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Angioedema (4536)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer last worked (b)(6) 2023 and got on disability because she is unable to wear masks provided at her place of work.Customer states there was redness and irritation to face, under eye to neck.A patch test was performed.Customer was prescribed antihistamines, prednisone, and an epipen for use in an allergic emergency.
Additional Manufacturer Narrative
The product involved in this complaint was not returned.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, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.
Additional Manufacturer Narrative
The product involved in this complaint was not returned.Lack of samples and lot number make it difficult to determine the root cause.Since visual and functional inspections cannot be performed, we cannot confirm or replicate the incident reported.Complaint trend was reviewed for code 32856 and failure mode "reaction" for the past 12 months from (b)(6) 2022 to (b)(6) 2023.There is no upward trend for the past 12 months.This information is submitted pursuant to 21cfr803, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).

• Common Device Name: ICP FACIAL PROTECTION
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA; km 4.5 carreterra presa; la amistad; ciudad de acuna, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17345228
• Report Number: 9616096-2023-00080
• Device Sequence Number: 6941202
• Product Code: OXZ
• UDI-Device Identifier: 30680651328565
• UDI-Public: 30680651328565
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 32856
• Device Catalogue Number: 32856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown