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

Catalog Number	AT74531
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the lot number was provided, the device history record was able to be reviewed, and no quality issues were reported during manufacture.Forty seven samples were received and evaluated.A mask was worn by five individuals for forty five minutes, no irritation was observed.All masks were made according to specification.No deviations were observed.All finished goods are made from qualified material that is tested before use.Final finished product must meet product specification and process requirements before final release to salable inventory.  based on the investigation, the issue was not confirmed and a root cause was not determined.No corrective action will be taken at this time.We will continue to monitor for complaints of this nature.
Event or Problem Description
Nurse had been using mask without problems.On (b)(6) 2016 nurse had her nose, cheeks, behind her ears, and arms break out with a rash.She went to occupational health and was given an antihistamine and topical ointment.

• 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: 6274370
• Report Number: 1423537-2017-00069
• Device Sequence Number: 89309
• Product Code: FXX
• UDI-Device Identifier: 10885380072116
• UDI-Public: 10885380072116
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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: Nurse
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: AT74531
• Device Lot Number: 16BFH610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2016
• Initial Report FDA Received Date: 01/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR