MAUDE Adverse Event Report: O&M HALYARD, INC. FLUIDSHIELD FOG-FREE PROCEDURE MASK WITH SO SOFT LINING AND EARLOOPS ORANGE; ICP FACIAL PROTECTION

Model Number	47107
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated it is difficult to breathe in because of the 3 layer thickness.Additional information was requested about this incident but not received.No further information provided.
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.H3 other text : device not returned.
Additional Manufacturer Narrative
The product involved in the event was not returned for evalation.The investigation was performed per information provided by the customer.A sample, photo or lot number was not available to perform an evaluation.We were unable to review the device history record for this complaint given the reporter did not provide a complaint lot number.We reached out to the customer for additional information and the reporter has not responded.Based on the information available and investigation performed, a root cause was not identified.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.H3 other text : device not returned.

• Brand Name: FLUIDSHIELD FOG-FREE PROCEDURE MASK WITH SO SOFT LINING AND EARLOOPS ORANGE
• 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 30087 ; 8287820529
• MDR Report Key: 18171838
• Report Number: 9616096-2023-00086
• Device Sequence Number: 7687592
• Product Code: FXX
• UDI-Device Identifier: 30680651471070
• UDI-Public: 30680651471070
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 47107
• Device Catalogue Number: 991047107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/16/2024
• 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
• Patient Sex: Unknown