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

Model Number	AT74535
Health Effect - Clinical Code	Reaction (2414)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based in the information provided for this particular code with lot number 19flh293 this product was manufactured on june 13th, 14th & 17th 2019 during first and second shifts.According with the device history record reviewed no quality issues were reported.We confirmed the following: we reviewed our batch history record and no quality issues of this nature were reported.All operators are certified in their respective operations.The failure mode and effect analysis (fmea) applicable to this product was reviewed.We verified that these devices are made with qualified, tested, and approved materials.Based on the code provided.The operators and the quality inspector did not identify this condition during their process and continuous inspection.Including destructive test and visual inspection for fibers and seal conditions.Since a sample was not provided at the time of the investigation the root cause could not be identified.As a preventive action we will maintain the following: awareness documented training was provided to the employees involved in the process of this product in order to be alert about this kind of issues.Our product is being maintained monitored by the quality inspector during their continuous inspection in order to prevent this kind of issues.At this time, there are no of additional actions until the potential root cause can be determined.
Event or Problem Description
Based on information received after phone conversation with the end-user, she clarified that she did go to the emergency department after having an alleged reaction to mask at74535 (fog free mask) lot number 19flh293.She received a prescription for 5-day steroids; however, she did not fill the prescription as she was seeing her dermatologist the next day.After see dermatologist she received an 8-week treatment of the antibiotic doxycycline.She stated she is doing much better.

• Brand Name: MASK SURGICAL FOG FREE FOAM
• 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: 9632161
• Report Number: 1423537-2020-00398
• Device Sequence Number: 2535736
• Product Code: FXX
• UDI-Device Identifier: 10885380072123
• UDI-Public: 10885380072123
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: AT74535
• Device Catalogue Number: AT74535
• Device Lot Number: 19FLH293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 75