MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. NATURAL EXTENSIONS EXTRA SENSITIVE EAR LOOP FACE MASK; SURGICAL MASK

Model Number	GPLUSWHB
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	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), distributor of natural extensions extra sensitive ear loop face mask, reported that a dental hygienist experienced symptoms of an allergic reaction while wearing the face mask.Crosstex followed up with the facility for additional information.It was reported the hygienist experienced symptoms of a hot, irritating sensation on her face.It was reported that the symptoms have been ongoing since (b)(6) 2018 with the use of several different face masks.It is unknown if all masks used were manufactured by crosstex.The hygienist is currently under medical supervision.The facility reported that the hygienist has a pre-existing condition (shingles) and multiple allergies.This complaint will continue to be monitored in the crosstex complaint handling system.
Event or Problem Description
(b)(4), distributor of natural extensions extra sensitive ear loop face mask, reported that a dental hygienist experienced symptoms of an allergic reaction while wearing the face mask.

• Brand Name: NATURAL EXTENSIONS EXTRA SENSITIVE EAR LOOP FACE MASK
• Common Device Name: SURGICAL MASK
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; hauppauge NY 11788
• MDR Report Key: 8655941
• Report Number: 2433773-2019-00003
• Device Sequence Number: 14022139
• Product Code: FXX
• UDI-Device Identifier: 10366975000658
• UDI-Public: 10366975000658
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: GPLUSWHB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/30/2019
• 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