MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL, INC. A CANTEL MEDICAL COMP ULTRA¿ SENSITIVE EARLOOP MASK; SURGICAL MASK

Model Number	GCFCXS
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rash (2033)
Date of Event	01/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Crosstex received a report through a distributor, (b)(6), that a physician experienced a rash after wearing the crosstex ultra sensitive earloop mask.Crosstex ra followed up with the dental facility at which this incident occurred and they reported the physician had itchiness and a rash around his face and ears within five minutes of applying the mask.The physician had previously worn the same mask and had no reaction.The physician sought medical attention and was prescribed a cortisone cream.The physician has since stopped using the mask and his symptoms have not yet cleared.There have been no other reports of reactions to this mask at the dental facility.The facility did not identify the lot number nor return product for quality analysis.This complaint will be monitored in the crosstex complaint handling system.
Event or Problem Description
Crosstex received a report through a distributor, (b)(6), that a physician experienced a rash after wearing the crosstex ultra sensitive earloop mask.

• Brand Name: ULTRA¿ SENSITIVE EARLOOP MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL, INC. A CANTEL MEDICAL COMP; 10 ranick road; hauppauge,, ny
• MDR Report Key: 9779651
• Report Number: 2433773-2020-00001
• Device Sequence Number: 2650486
• Product Code: FXX
• UDI-Device Identifier: 10732224120017
• UDI-Public: 10732224120017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 03/03/2020

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 Model Number: GCFCXS
• Device Catalogue Number: GCFCXS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/03/2020
• 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