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 Code	Reaction (2414)
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 19dgh616 this product was manufactured on april 29th, 30th & may 01st 2019 during first and second shifts.According with the device history record reviewed no quality issues were reported.At the time of this investigation no sample was received.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.Since a sample was not provided at the time of the investigation the 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 after a phone conversation with the end-user, she clarified that she did go to the emergency department after having an alleged reaction to mask at73335, lot number 19dgh616.She stated she was prescribed 5-day oral steroids and hydrocortisone cream 2%.

• 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: 9617693
• Report Number: 1423537-2020-00396
• Device Sequence Number: 10888494
• 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): 01/22/2020

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: 19DGH616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 165