MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5; MASK, GAS, ANESTHETIC

Model Number	VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that during an operation, the customer had circular dermatitis at the contact area of the 6850 vital signs® adult face mask with adjustable air cushion size 5, as an intervention, the patient will have a dermatitis check up.
Additional Manufacturer Narrative
The sample has been discarded, however the device history record review was requested to determined the root cause of the issue.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
The device history record of the p/n 6850 with lot number 0004181995 and udi code (b)(4).Was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured on 13apr2021 per our internal procedures and no issues were found.According to investigation, we could not confirmed the reported defect.In the product label indicates must consult instructions for use, prior to use in the patient.

• Brand Name: VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
• Common Device Name: MASK, GAS, ANESTHETIC
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12983666
• Report Number: 8030673-2021-00221
• Device Sequence Number: 14767732
• Product Code: BSJ
• UDI-Device Identifier: 10190752147461
• UDI-Public: (01)10190752147461(10)0004181995
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
• Device Catalogue Number: 6850
• Device Lot Number: 0004181995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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