MAUDE Adverse Event Report: HALYARD HEALTH PROCEDURE MASK BLUE; ICP FACIAL PROTECTION PRODUCTS

Model Number	47080
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Codes	Asthma (1726); No Code Available (3191)
Date of Event	02/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Allergic reaction, shortness of breath, elevated heart rate the sample is reported to be available, but has not yet been received by the manufacturer.The device history record for am6305131 was reviewed and the product was produced according to product specifications.Halyard health 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 halyard health 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 halyard health product is defective or caused serious injury.Not returned.
Event or Problem Description
It was reported that after wearing the mask, a nurse experienced an asthma attack with shortness of breath and elevated heart rate.The nurse feels it was due to an allergic reaction to the mask.The hospital alleges there is an odor but has provided no further details at this time.
Additional Manufacturer Narrative
The sample was returned and evaluated.The samples were received with 198 masks, with lot number am6305131 product code 47080.The 198 masks were received as representative samples for evaluation.8 masks were evaluated aleatory with 8 people, the samples were tested for one hour, and the result was that they didn't cause anything like a reaction in their face.Occasionally external conditions and personal allergies may contribute to skin allergy as no roughness was shown in the masks.According to samples show correct materials were used during the manufacture.This issue cannot be confirmed.All information reasonably known as of (b)(6) 2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint comp-(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 halyard health product is defective or caused serious injury.

• Brand Name: PROCEDURE MASK BLUE
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6406761
• Report Number: 9616096-2017-00001
• Device Sequence Number: 512188
• Product Code: FXX
• UDI-Device Identifier: 30680651470806
• UDI-Public: 30680651470806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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: Nurse
• Device Expiration Date: 10/13/2021
• Device Model Number: 47080
• Device Catalogue Number: 991047080
• Device Lot Number: AM6305131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 05/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other