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 Code	Foreign Body In Patient (2687)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided, therefore the device history record was able to be reviewed, and no quality issues were reported.The customer reported having a sample, but as of this date, no sample has been received from them.Without the sample, we cannot identify the root cause.If a sample is provided at a later date, a follow up report will be filed.This mask is made with qualified, tested, and approved materials.All operators are certified in their respective operations.Awareness training was provided to the involved employees.We will continue to monitor complaints for any such issues.
Event or Problem Description
Nurse went to put on a mask and was hit with a white powdery substance in her eye.Customer states it is standard policy for employees to seek care/evaluation from employee health services.The nurse was not symptomatic, but as standard protocol, an eyewash was performed.The nurse is a contractor, so the customer did not have any personal information about her.
Additional Manufacturer Narrative
The manufacturing facility received the samples on may 14, 2018, and their investigation confirmed the issue.The root cause of the white powdery substance is linting of the mask materials due to the friction of the material during the manufacturing process.We verified that the mask is made with qualified, tested, and approved materials; and that the product was manufactured according to specification.All operators were trained and certified in their respective assembly operations.As stated on the initial medwatch report, the lot number was provided, therefore the device history record was reviewed, and no quality issues were reported.The following actions will be implemented to prevent this event from recurring: awareness documented training was provided to the involved employees to alert them to this issue.A quality alert will be generated to inform employees at similar processes of this issue.A more effective method for cleaning the equipment will be defined in order to reduce the risk of residues occurring from the friction of the material during the manufacturing process.We will continue to monitor complaints for issues of this nature.

• 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: 7477283
• Report Number: 1423537-2018-00195
• Device Sequence Number: 11133367
• Product Code: FXX
• UDI-Device Identifier: 10885380071997
• UDI-Public: 10885380071997
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 06/06/2018

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: Nurse
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: AT70021
• Device Lot Number: 18CKH013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other