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	Bronchitis (1752); Sore Throat (2396)
Date of Event	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint was forwarded to plant for investigation.Plant awaiting sample return.Will file follow up medwatch report once plant receives and evaluates sample.
Event or Problem Description
Home dialysis patient received masks that he says are dusty/have lots of lint and make him cough/sneeze/get a sore throat.He saw his family physician and was diagnosed with bronchitis, which he states his physician said is due to the masks.He was prescribed antibiotics.He is now using a different mask, apparently without problems.
Additional Manufacturer Narrative
This follow up report is based on sample receipt.The lot number was provided, therefore the device history record was reviewed, and  no quality issues were reported.(b)(4) samples were received, and were evaluated for dimensions, folds, foreign particles / fibers on the surface.A sample mask was worn for 45 minutes, and no defects were observed.Based off of the evaluation of the samples, the issue was not confirmed.There is no corrective action at this time, however we will continue to monitor complaints for such issues.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.

• 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: 6086491
• Report Number: 1423537-2016-00057
• Device Sequence Number: 775012
• Product Code: FXX
• UDI-Device Identifier: 10885380071997
• UDI-Public: 10885380071997
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2016

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: Lay User/Patient
• Device Expiration Date: 03/14/2021
• Device Catalogue Number: AT70021
• Device Lot Number: 16CGH319
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 10/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2016
• Supplement Report FDA Received Date: 12/01/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 78