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	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based in the information provided for this particular code with lot number 19egh567 this product was manufactured on may 23rd, 24th, 25th and 27th 2019 during first and second shifts.Per the device history record, no quality issues were reported.We confirmed the following: we reviewed our batch history record and no quality issues of this nature were reported.All operators are certified in their respective operations.The failure mode and effect analysis (fmea) applicable to this product was reviewed.We verified that these devices are made with qualified, tested, and approved materials.Based on the code provided.The operators and the quality inspector did not identify this condition during their process and continuous inspection.Including destructive test and visual inspection for fibers and seal conditions.Product was made to meet with their specification requirements.A sample was not provided at this time.At this time a root cause could not be identified.As a preventive action we will maintain the following: awareness documented training was provided to the employees involved in the process of this product in order to be alert about this kind of issues.Our product is being maintained monitored by the quality inspector during their continuous inspection in order to prevent this kind of issues.Seals and (b)(4) material are been monitored ensuring they do not present conditions that may affect the final user.
Event or Problem Description
Based on information received by the end-user, employee (b)(6) reportedly was seen at two different urgent care centers with alleged symptoms of a burning feeling around her mouth, face and neck.She also alleges breaking out 2 to 10 hours later that progressively got worse.She was prescribed decadron and hydrocortisone 0.2% ointment on her first visit urgent care visit.On her second visit to urgent case she was prescribed prednisone 5-day pack and to continue use of topical cream and benadryl.

• 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: 9582374
• Report Number: 1423537-2020-00393
• Device Sequence Number: 18925901
• Product Code: FXX
• UDI-Device Identifier: 10885380072079
• UDI-Public: 10885380072079
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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: No Information
• Device Model Number: AT73335
• Device Catalogue Number: AT73335
• Device Lot Number: 19EGH567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 75