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

Catalog Number	AT70021
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Irritation (1941); Rash (2033); Swelling (2091)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was reviewed, and no quality issues were reported.A review of this product catalog number identified no trends for this issue in the last twelve months.The sample was not available for evaluation as it had been discarded after use.The reported lot number did not match the manufacturing records, however the manufacturing facility was able to identify the suspected lot number.It was verified that these devices are made with qualified, tested, and approved materials; and that the product was made to meet specification requirements.The mask is not made with natural rubber latex, and this material is not used in our manufacturing processes.The potential root cause could not be identified.All operators are certified in their respective operations.Awareness documented training was provided to the involved employees to alert them of this issue; and the product is monitored by a quality inspector.We will continue to monitor complaints for any such issues.
Event or Problem Description
Nurse wore mask majority of shift.Noticed nose/neck/lower jawline was red and irritated - irritated areas proceeded to a red rash.Saw family physician who thought it was contact dermatitis from the mask and prescribed prednisone and zantac.Symptoms persisted extending to lower neck, throat (irritated, glands swollen), and hands having rash on knuckles.She then saw the employee health physician who believed it was an allergy to latex.She is taking a tapering pack of methylprednisone and hydrocortisone cream, and is to see an allergist.The nurse is not certain if the mask caused her symptoms.Cardinal health is proactively filing this.

• 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
• MDR Report Key: 8427272
• Report Number: 1423537-2019-00290
• Device Sequence Number: 240524
• Product Code: FXX
• UDI-Device Identifier: 20885380071994
• UDI-Public: 20885380071994
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/17/2019

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 Expiration Date: 05/01/2023
• Device Catalogue Number: AT70021
• Device Lot Number: 18ELH179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/17/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Weight: 71