MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. ULTRA SENSITIVE EARLOOP W/ SECURE FIT FACE MASK; SURGICAL MASK

Model Number	GCFCXSSF
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Rash (2033); Skin Irritation (2076); Swelling (2091); Confusion/ Disorientation (2553)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dental office reported that a hygienist at the facility experienced allergic reaction symptoms after wearing a crosstex ultra sensitive secure fit face mask for the first time.The dental office contacted crosstex to report the reaction and was provided the technical data sheet for mask materials information.Crosstex followed up with the facility for more information on the reported reaction.It was reported the hygienist took benadryl right away and had experienced symptoms of red skin, confusion and irritation, difficulty breathing, swollen tongue and difficulty swallowing.The facility contacted paramedics who provided oxygen.It was reported the hygienist did not experience any lasting symptoms and her current condition is fine.Other personnel in the office have worn the same face masks without any reactions.A review of the device history record indicates the mask was manufactured per crosstex specifications and no issues were noted.Crosstex has not received any similar complaints for this lot.This complaint will continue to be monitored in the crosstex complaint handling system.
Event or Problem Description
A dental office reported that a hygienist experienced allergic reaction symptoms, including anaphylaxis, while wearing a crosstex ultra sensitive secure fit face mask for the first time.

• Brand Name: ULTRA SENSITIVE EARLOOP W/ SECURE FIT FACE MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 7855043
• Report Number: 2433773-2018-00003
• Device Sequence Number: 13787771
• Product Code: FXX
• UDI-Device Identifier: 10732224120062
• UDI-Public: 10732224120062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K012602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: Health Professional
• Device Model Number: GCFCXSSF
• Device Lot Number: 20180215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/07/2018
• 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