MAUDE Adverse Event Report: O&M HALYARD, INC. PFR95 PART FILT RESP; ICP FACIAL PROTECTION

Model Number	46727
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	Serious Injury
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.
Event or Problem Description
A medwatch report (mw5145095) was received through fda¿s medwatch program on (b)(6) 2023.The customer contracted covid-19 and was fully vaccinated.Customer indicated they were extremely careful wearing a clean halyard n95 duckbill mask.Almost a year later the customer still suffers with long-term covid symptoms and side effects that are impacting their health and wellness.The initial binaxnow covid-19 test was confirmed with ihealth and sent to the cdc.Customer subsequently indicated they suspected they caught covid on a plane from london to sfo.Customer was masked on the plane flight other than when quickly eating.There was no medical intervention other than over the counter medication.The customer indicated they have residual fatigue, muscle aches, tingling feet and elbow, overactive bladder, and increase in hemoglobin.Customer follows up with physician regularly but never had any of these issues prior to contracting virus.
Additional Manufacturer Narrative
The product involved in this complaint was not returned for evaluation.The device history records (dhr) evaluation was performed for product code: 46727 identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedure and specifications, then released by quality assurance.A quality nonconformance was not reported at the time of production.Manufacturing conducts visual and functional inspections throughout production.The materials corresponding to product: 46727 were analyzed and according to the incoming inspection the raw material was in conformance with specification.A root cause was not identified.Notification was sent to manufacturing leaders for awareness.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.

• Brand Name: PFR95 PART FILT RESP
• 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: 17749154
• Report Number: 9616096-2023-00084
• Device Sequence Number: 5235441
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K974068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: Lay User/Patient
• Device Model Number: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: AMO121831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 11/15/2023
• 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