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

Model Number	AT70021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident was reported for an associate that experienced an allergic reaction to a cardinal health mask.The team member had to be prescribed a 7-day treatment of prednisone to treat severe dermatitis.We have not received any additional follow up after several requests.
Additional Manufacturer Narrative
A sample was not provided for investigation.We have verified that these devices are made with qualified, tested, and approved materials.This product was made to meet with the specification requirements.The failure mode and effect analysis applicable to this product was reviewed.It was found that the product is not made with natural rubber latex, and the product is labeled for single use.Without a sample a root cause could not be determined.The complaint information was shared with the relevant sectors for their awareness.There is no action taken at this time, we will continue to monitor trends of this type of incident.

• Brand Name: MASK PROCEDURE YELLOW
• 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
• Manufacturer (Section G): QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V.; ave. rio sta. clara - lotes 12; cuauhtemoc, chihuahua 31543 ; MX 31543
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 12956663
• Report Number: 1423537-2021-00694
• Device Sequence Number: 11210610
• Product Code: FXX
• UDI-Device Identifier: 10885380071997
• UDI-Public: 10885380071997
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: Health Professional
• Device Model Number: AT70021
• Device Catalogue Number: AT70021
• Device Lot Number: 21FQH614
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown