MAUDE Adverse Event Report: QUIROPRODUCTOS DE CUAUHTEMOC S. DE R.L. DE C.V. MASK, SURGICAL SOFT-TOUCH SENSITIVE WHT

Catalog Number	AT73035
Health Effect - Clinical Code	Skin Irritation (2076)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved lot number was not provided, therefore the device history record could not be reviewed.This issue needs to be investigated by sample evaluation; however the sample was not available for investigation, therefore the root cause could not be determined.All manufactured product is made from qualified materials that are inspected prior to release to manufacturing for production.In addition, all manufactured product must meet product specification and manufacturing process requirements before final release.All operators are certified in their respective operations.Documented awareness training was provided to the employees involved in the processing of this product alerting them to this kind of issue.We will continue to monitor complaints regarding such issues.
Event or Problem Description
Sales rep was notified that (b)(6) was on steroids because of skin irritation issues with the mask.The customer did not provide any additional specifics regarding the crna and the event.

• Brand Name: MASK, SURGICAL SOFT-TOUCH SENSITIVE WHT
• 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: 7887952
• Report Number: 1423537-2018-00238
• Device Sequence Number: 2488455
• Product Code: FXX
• UDI-Device Identifier: 10885380072062
• UDI-Public: 10885380072062
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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 Catalogue Number: AT73035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other