MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. ISOFLUID EARLOOP WITH SECURE FIT TECHNOLOGY SURGICAL MASK

Model Number	GCIBLSF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Local Reaction (2035)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Crosstex received a report through our distributor, (b)(4).It stated a dentist at the facility reported experiencing allergic reaction symptoms after wearing the surgical masks for the first time.Crosstex followed up with the dentist at the facility.The dentist reported using the masks for 2 weeks and experienced allergic reaction symptoms for about 3 weeks.Additional medical attention was sought.She took prescribed allergy medication to alleviate the symptoms.The dentist speculated the rash being due to use of new gloves, but noted the reaction was mostly localized to her face.The dentist reported her current condition to be fine.Crosstex has not received similar complaints related to the isofluid surgical masks.This complaint will continue to be monitored in the crosstex complaint handling system.Device not returned.
Event or Problem Description
A dentist at the facility reported experiencing allergic reaction symptoms to her hands and face after wearing the surgical mask for the first time.

• Brand Name: ISOFLUID EARLOOP WITH SECURE FIT TECHNOLOGY SURGICAL MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 6559015
• Report Number: 2433773-2017-00001
• Device Sequence Number: 16164020
• Product Code: FXX
• UDI-Device Identifier: 10732224120123
• UDI-Public: 10732224120123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Dentist
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: Dentist
• Device Model Number: GCIBLSF
• Device Lot Number: 10 20170124
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/10/2017
• 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