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

Model Number	AT73335
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/1980
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Consumer reported allergic reactions to the mask and history of allergies.She reports never having to wear a surgical mask before, but now wears the mask for at least 12 hours during her work day and is having breathing problems such as coughing, asthma-like symptoms.She is the only one having an allergic reaction.
Additional Manufacturer Narrative
The actual/suspected device was returned for investigation.Based on the information provided for this particular product code with lot number 20dhh775 this product was manufactured on april 20, 2020 during the second shift.The device history record was reviewed and no quality issues were reported.Additionally, we reviewed our batch history record and no quality issues of this nature were reported.The returned actual/suspected device was evaluated and the reported issue was not confirmed.The evaluation revealed no condition was found in our process that could cause the reported defect.According to our investigation and actual/suspected device evaluation, we verified that these devices are made with qualified, tested, and approved materials for the product code provided.In addition, a review of our records revealed all operators are certified in their respective operations.The reported issue was not confirmed; therefore, no correction actions were implemented.We will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: MASK SURGICAL 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: 10540622
• Report Number: 1423537-2020-00523
• Device Sequence Number: 14243521
• Product Code: FXX
• UDI-Device Identifier: 50885380072077
• UDI-Public: 50885380072077
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: Other
• Device Expiration Date: 04/01/2025
• Device Model Number: AT73335
• Device Catalogue Number: AT73335
• Device Lot Number: 20DHH775
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 12/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other