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

Model Number	47117
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is reportedly available for this complaint but was not returned when this report was filed.All information reasonably known as of 04may2020 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 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 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.Other text : device not returned.
Event or Problem Description
O&m halyard, inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 9616096-2020-00002 for the second patient.Refer to 9616096-2020-00003 for the third patient.It was reported that staff members had a reaction and reported respiratory distress to employee health during use wearing an (unknown product number) yellow procedure mask.Additional information was received on 23-april-2020 that states the product code identified was 47117 and lot number lot: am0073101.It was reported that 3 have employees reported to employee health for itching, burning, to rashes, difficulty breathing, and an employee used benadryl.The employees changed the mask to after having a reaction.Additional information was received on 24-april-2020 that states (2) facilities listed for this complaint (b)(6) medical center, different addresses, same alert date and stock codes.Additional information was received on 28-april-2020 that states the duration of use wearing the mask was between 5 minutes to 8-12 hours.There was no medical intervention provided and the issue was resolved and stopped "when the mask was not worn, or the type/brands were changed." no additional information provided.
Additional Manufacturer Narrative
We received three (3) unused representative samples with no product packaging.The samples were evaluated under ambient light conditions.The samples were found to be assembled according to the specification drawing.All three (3) samples were inspected on the outside and the inside.There are no sharp edges, no protruding fibers or foreign materials observed.One mask exhibits what appears as two bond points where there may be holes.One apparent hole is observed from the outside of the mask at the top of the mask and the other apparent hole is observed at the bottom of the mask in the area of ultrasonic bonding.The areas were viewed under magnification.The holes at both bond points is confirmed.The layer of material is missing inside the bond points.We are unable to confirm the complaint of allergic reaction with the evaluation performed in the lab.The device history records (dhr) evaluation was performed for the product code 104711765 and lot number am0073101 that was identified in this complaint.According to the documented records, the product was manufacturing according to the approved manufacturing procedures, specifications and then released by quality assurance.A quality nonconformance was not reported at the time of production.All information reasonably known as of 30jun2020 has been included in this health authority report.Should additional information be obtained.The information provided by o&m halyard, inc.Represents all of the known information at this time.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 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.

• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): OWENS & MINOR HALYARD; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10024149
• Report Number: 9616096-2020-00001
• Device Sequence Number: 2502642
• Product Code: FXX
• UDI-Device Identifier: 30680651471179
• UDI-Public: 30680651471179
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K823078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

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 Expiration Date: 03/13/2025
• Device Model Number: 47117
• Device Catalogue Number: 991047117
• Device Lot Number: AM0073101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other