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

Catalog Number	AT74531
Health Effect - Clinical Codes	Rash (2033); Swelling (2091)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer was not able to identify the lot number, therefore the device history record could not be reviewed.The actual mask worn was discarded after use.The customer also stated they did not know which box the mask had been pulled from; and due to high usage, the box was probably empty by now, therefore a representative sample also was not available.Since a sample was not provided for evaluation, the root cause could not be identified.It was verified that this device is made with qualified, tested, and approved materials; and the device is made to meet specification requirements.Awareness documented training was provided to the employees involved in the processing of this product in order to make them aware of this issue.All operators are certified in their respective operations.We will continue monitoring customer complaints for issues of this nature.
Event or Problem Description
Nurse¿s face was itchy/red/broke out in rash and hives; and later that night her face became swollen.The next day she went to the urgent care because her face was still swollen and broken out.She received a steroid injection, po steroids, and po antihistamines.These helped, and her face went back to normal within a few days.

• Brand Name: MASK, PROCEDURE
• 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: 8346505
• Report Number: 1423537-2019-00271
• Device Sequence Number: 2285101
• Product Code: FXX
• UDI-Device Identifier: 10885380072116
• UDI-Public: 10885380072116
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2019

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: AT74531
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 02/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 22 YR
• Patient Weight: 77