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

Model Number	AT74531
Health Effect - Clinical Code	Rash (2033)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual event sample was provided for investigation.Based on the lot number reported, 20cmh195, this product was manufactured on march 14th 2020.The review of our batch history record for this lot number revealed no quality issues of this nature were reported.All operators are certified in their respective operations.The failure mode and effect analysis (fmea) applicable for this product was reviewed.We verified that these devices are made with qualified, tested, and approved materials based on the code provided.Based on our manufacturing processes of this product, we can determine that the defect reported occurred possibly in some of the following processes, assembly, sealing or due to the material used.Awareness documented training was provided to the employees involved in the process of this product in order to be alert about this kind of issue.Our product is being maintained monitored by the quality inspector during their continuous inspection in order to prevent this kind of issue.Seals and raw material are being monitored ensuring they do not present conditions that may affect the end user.We will continue to monitor the trend of this type of incident.
Event or Problem Description
Employee in imaging services reported developing skin irritation/rash after wearing mask.Employee has a latex allergy.She went to the emergency department with eye swelling and was given oral prednisone.Employee finished prednisone dose pack and reports she is doing fine now.

• 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: 10103897
• Report Number: 1423537-2020-00465
• Device Sequence Number: 2706771
• Product Code: FXX
• UDI-Device Identifier: 10885380072116
• UDI-Public: 10885380072116
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/31/2020

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 Expiration Date: 03/01/2025
• Device Model Number: AT74531
• Device Catalogue Number: AT74531
• Device Lot Number: 20CMH195
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Weight: 86