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

Model Number	46727
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Viral Infection (2248)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was not available for return.There was no lot number provided by the reporter, therefore, no dhr record review was possible to determine if anything happened during manufacture that could possibly contribute to the issue.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 has caused serious injury.
Event or Problem Description
A medwatch report (mw5116813), was received on (b)(6)2023 from the fda¿s medwatch program for a viral infection (covid).I am a primary care physician and i had a huge box of these respirators from 2022 that i recently used up and just started using a newly ordered box which i received in (b)(6)2023.I took a rapid covid test before visiting my parents, and i was somewhat surprised to see a positive result.My immediate family all tested negative.
Additional Manufacturer Narrative
The product involved in the event was not available for return.There was no lot number provided by the reporter, therefore, no dhr record review was possible to determine if anything happened during manufacturing that could possibly contribute to the issue.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, 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 has caused serious injury.H3 other text : device not returned.

• Brand Name: PFR95 PART FILT RESP
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUÑA; 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: 16991955
• Report Number: 9616096-2023-00003
• Device Sequence Number: 17883964
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 46727
• Device Catalogue Number: 991046727
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/03/2023
• 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: Female