MAUDE Adverse Event Report: QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. CARDINAL HEALTH LEVEL 1 PROCEDURE MASK E; MASK, SURGICAL

Model Number	AT70021UC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Caustic/Chemical Burns (2549)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the investigation, the device history record could not be reviewed as the lot number provided was incorrect.A sample was not available for investigation.The devices are made with qualified, tested, and approved materials.The product is not made with natural rubber latex.All quality assurance testing performed during the manufacturing process for this product was acceptable and met the specification requirements.Therefore, the root cause for the reported concern cannot be identified with the information provided.We will continue to monitor concerns such as these for possible future actions.All personnel have been made aware of this reported incident through the investigation process.
Event or Problem Description
A patient reported through medwatch report #mw5103107 that they received chemical burns/rash after wearing a cardinal health level 1 procedure mask.According to report, their face began to sting and peel.They also had chemical burns on their nose, inner eye, and cheek area from the mask.No further information was provided after multiple attempts to reach customer.

• Brand Name: CARDINAL HEALTH LEVEL 1 PROCEDURE MASK E
• 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: 12641046
• Report Number: 1423537-2021-00679
• Device Sequence Number: 6142895
• Product Code: FXX
• UDI-Device Identifier: 10885380071997
• UDI-Public: 10885380071997
• Combination Product (Y/N): N
• 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): 10/15/2021

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: Lay User/Patient
• Device Expiration Date: 12/30/2025
• Device Model Number: AT70021UC
• Device Catalogue Number: AT70021UC
• Device Lot Number: 20MMGNA365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/15/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5103107
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other