MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC MASK, PROCEDURE, BLUE; MASK, SURGICAL

Catalog Number	AT71021
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record could not be reviewed as the lot number was not available.As of this date, the sample has not been received, therefore the root cause could not be determined.If the sample is received, a follow up report will be filed.The complaint information was shared with the relevant sectors for their awareness.The mask ingredients were shared with shoreline allergy.This mask has been tested and met requirements for biological clearance for use.Testing was performed per fda memorandum (b)(4), aami/ansi/iso (b)(4) per fda recognition (b)(4) for cytotoxicity, irritation, and sensitization.There is no additional action taken at this time, but we will continue to monitor complaints for any trends.
Event or Problem Description
Nurse sought treatment from shoreline allergy stating she had had an anaphylactic reaction to the mask.Shoreline allergy contacted cardinal health for mask ingredients.They state nurse is doing fine.

• Brand Name: MASK, PROCEDURE, BLUE
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 1 butterfield trail blvd; el paso TX 79906
• MDR Report Key: 7365433
• Report Number: 1423537-2018-00172
• Device Sequence Number: 11133528
• Product Code: FXX
• UDI-Device Identifier: 10885380072017
• UDI-Public: 10885380072017
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: Nurse
• Device Catalogue Number: AT71021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 92