MAUDE Adverse Event Report: QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. MASK SURGICAL FOGFREE ANTI GLARE; MASK, SURGICAL

Catalog Number	AT74635-I
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer could not provide the lot number.Without the lot number, the device history record could not be reviewed.The customer discarded the sample.Without the sample, the root cause could not be identified.These devices are made with qualified, tested, and approved materials.The product was made to meet specification requirements, and is not made with natural rubber latex.A review of this product catalog number identified no trends for this issue in the last twelve months.We will continue to monitor complaints for such issues.Awareness documented training was provided to the involved employees, and the quality inspector will continue to monitor the product.
Event or Problem Description
Nurse states ¿during the procedure my nose was itching, by the end of the day i had hives around the right side of my mouth.The next day my whole face was swollen¿.She saw a physician and was told to keep taking benadryl every 6 hours and was prescribed a prednisone pack for 6 days.

• Brand Name: MASK SURGICAL FOGFREE ANTI GLARE
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.; ave. rio sta. clara - lotes 12; cuauhtemoc, chihuahua 31543 ; MX 31543
• MDR Report Key: 8492342
• Report Number: 1423537-2019-00305
• Device Sequence Number: 19263351
• Product Code: FXX
• UDI-Device Identifier: 20885380072151
• UDI-Public: 20885380072151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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 Catalogue Number: AT74635-I
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Weight: 70