MAUDE Adverse Event Report: QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. MASK SURG DUCKBILL SENSITIVE WHITE; MASK, SURGICAL

Catalog Number	AT51334
Health Effect - Clinical Codes	Rash (2033); Swelling (2091)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided, therefore the device history record was able to be reviewed, and no quality issues were reported.The sample was not provided for evaluation, therefore 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.A review of this product catalog number identified no trends being detected for this issue in the last twelve months.Awareness documented training was provided to the employees involved in the processing of this product in order to make them aware of this issue.We will continue monitoring customer complaints for issues of this nature.
Event or Problem Description
Face broke out in a blister like rash.She put on the mask and within an hour was covered in a rash.She will be seeking medical attention, and has a history of being placed on steroid cream.Customer did not want to provide specifics (age, weight etc).

• Brand Name: MASK SURG DUCKBILL SENSITIVE WHITE
• 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: 8328769
• Report Number: 1423537-2019-00268
• Device Sequence Number: 1619838
• Product Code: FXX
• UDI-Device Identifier: 10885380072093
• UDI-Public: 10885380072093
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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 Expiration Date: 10/01/2023
• Device Catalogue Number: AT51334
• Device Lot Number: 18KDH335
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other