N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. ATTEMPTS WERE MADE TO ACQUIRE ADDITIONAL INFORMATION FROM AMAZON REGARDING THE INCIDENT, HOWEVER THE REVIEWER'S POST DID NOT PROVIDE ANY CONTACT INFORMATION AND WAS POSTED ANONYMOUSLY; THEREFORE, INVESTIGATION AND ADDITIONAL INCIDENT DETAILS WERE LIMITED. NO LOT NUMBER WAS PROVIDED; THEREFORE, A DHR REVIEW WAS NOT POSSIBLE. NO SAMPLES WERE AVAILABLE SO AN EVALUATION WAS NOT POSSIBLE. A 12 MONTH TREND REVIEW FOR THE PRODUCT CODE WAS CONDUCTED. THERE WERE NO SIMILAR INSTANCES WHERE MASK USE CAUSED A STYE. THIS INCIDENT APPEARS ISOLATED. THE MANUFACTURING SITE PERFORMS MONTHLY TRENDING ANALYSIS AND WILL CONTINUE TO MONITOR FOR ANY CORRECTIVE ACTION NEEDS. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT: (B)(4). H3 OTHER TEXT: DEVICE NOT RETURNED.

Additional Manufacturer Narrative

THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4)..

Description of Event or Problem

AN ANONYMOUS AMAZON REVIEW WAS RECEIVED WHICH INDICATES WHILE WEARING THE MASK, THE CUSTOMER GOT STYES ON TWO SEPARATE OCCASIONS. ADDITIONAL QUESTIONS WERE REQUESTED FROM AMAZON (THE CUSTOMER), NO RESPONSE HAS BEEN RECEIVED TO-DATE.