MAUDE Adverse Event Report: MAKRITEINDUSTRIES INC/SUREONDUSTRIES SECURE-GARD; N95 HEALTHCAREPARTICULATE RESPIRATOR

Model Number N95-S

Device Problem Human-Device Interface Problem (2949)

Patient Problem Local Reaction (2035)

Event Date 11/28/2014

Event Type  Injury  

Event Description

Nurse have many allergies to many different products experienced a near anaphylactic shock when she wore the above reference mask, she required medication.

Manufacturer Narrative

The returned product was manufactured by us.However, the lot number of the returned products did not match the lot number provided to us by the initial reporter.Therefore, we cannot determine if the allergic reaction was caused by our mask.Furthermore, examination of the returned products meets all manufacturing specifications and does not show any evidence of contamination or damage.We, therefore, consider this report complete to the best of our knowledge.

• Brand Name: SECURE-GARD
• Type of Device: N95 HEALTHCAREPARTICULATE RESPIRATOR
• Manufacturer (Section D): MAKRITEINDUSTRIES INC/SUREONDUSTRIES; no. 18 guangyuan st.; 168 industrial area; tang xia, dongguancity, guangdong ; CH
• Manufacturer Contact: zho ling ; no. 18, guangyuan st.; 168 industril area; tang xia, dong guan city, guangdong ; CH
• MDR Report Key: 4620879
• MDR Text Key: 5577784
• Report Number: 9614598-2015-00001
• Device Sequence Number: 1
• Product Code: FXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2017
• Device Model Number: N95-S
• Device Lot Number: 022714
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other