MAUDE Adverse Event Report: O& M HALYARD, INC PROCEDURE MASK WITH SO SOFT* EARLOOPS, YELLOW; ICP FACIAL PROTECTION PRODUCTS

Model Number	47117
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported she exhibited a reaction on her face and neck as a result of mask use.On (b)(6) 2022, customer reported itching/burning.Customer treated with antihistamine and cortisone cream.On 01sep2022, customer reported itching/burning sensation, increased redness, oozing behind ears, progression of irritation to eyes, forehead, neck and chest areas.On (b)(6) 2022, physician prescribed prednisone shot and oral prednisone for contact dermatitis and rash.The following week, skin reaction progressed throughout body with various spots, blisters, and patches occurring (abdomen, arms, back, upper legs, behind knees).On (b)(6) 2022, the customer was prescribed more prednisone.The skin reactions continued to flare in some spots and thigh areas.On (b)(6) 2022, physician prescribed additional prednisone 60mg per day and referred customer to allergist/immunologist.On (b)(6) 2022, allergist confirm reaction.No further updates from customer are available thereafter.
Additional Manufacturer Narrative
The product involved in the event reported is not available for evaluation.Upon conclusions of the complaint investigation a follow up report will be submitted.All information reasonably known as of 18oct2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.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.
Additional Manufacturer Narrative
The product involved in the event reported was not made available for evaluation.This product undergoes a ansi/asqz 1.4 aql 1.0 level s-4 sample inspection prior to release to market.Given no lot number was provided, the investigation site is unable to perform a device history record (dhr) review for the product involved.O&m halyard conducts a product safety assessment for all products.This documentation has been reviewed for the face mask.The health hazard assessment conclusions indicate a low patient or end-user risk associated.Cleanliness procedures govern manufacturing areas.Surfaces are cleaned with 70% ipa at minimum once per shift.Clothing and hair net requirements are specified for teammates working in manufacturing environment.Hand washing and sanitizer is required prior to entry.All information reasonably known as of 29nov2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information on at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedure details to o&m halyard, inc.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-ghc-22-00751.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.

• 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 ACUNA S. DE R.L DE C.V; av. hidalgo # 6; colonia parque industrial; nogales, sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15624286
• Report Number: 9616096-2022-00006
• Device Sequence Number: 6345406
• Product Code: FXX
• UDI-Device Identifier: 30680651471179
• UDI-Public: 30680651471179
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: Other
• Device Model Number: 47117
• Device Catalogue Number: 991047117
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 11/30/2022
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG