MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MASK,FACE,MAX FLUID PROTECT,EARLOOP

Catalog Number	NON27712EL
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the end-user went into anaphylactic shock related to use of the face mask.Per the reporting facility, no definitive issue with the face mask in question was identified.It was unknown what medical intervention was required as a result of the reported anaphylactic shock.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.Due to the reported anaphylactic shock and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause cannot be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the end-user went into anaphylactic shock related to use of face mask.

• Common Device Name: MASK,FACE,MAX FLUID PROTECT,EARLOOP
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7556622
• Report Number: 1417592-2018-00046
• Device Sequence Number: 19436283
• Product Code: FXX
• UDI-Device Identifier: 10080196754441
• UDI-Public: 10080196754441
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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 Catalogue Number: NON27712EL
• Device Lot Number: 13MA04111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/31/2018
• 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