MAUDE Adverse Event Report: EMBRACE HEALTHCARE LLC MASK, FULL FACE W/VELCRO STRAP VENTED FOAM; ACCESSORY, SURGICAL APPAREL

Catalog Number 23-001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the qfi report was reviewed for sales and similar complaint information.(b)(4).There have been no previous quality reports for the device.Within the text of the complaint, it is stated, "dr.Wearing shield as normal wears shield.Account was using our shields in place of their normal face shield that was on back order (splash shield in is name of their normal used face shield.) our face shield as described by account as too flimsy and too much of a gap from front shield and face allowing fluid to splash up on face.Account has asked for us to take back any open cases of product." the above statement indicates that the deroyal product was being utilized instead of an alternate vendor's product.It is unknown if the affected individual followed the provided ifu to application of the device.In addition, the ifu states, "the deroyal face shield is intended to reduce potential exposure against splashes, splatter, and droplets of blood or other bodily fluids."correction: a credit has been provided for one each.Root cause analysis: the report has been determined to be an isolated event.A potential root cause for the issue has been identified as end user error.Corrective action: due to the root cause determination, a corrective action has not been taken.Preventive action: due to the root cause determination, a preventive action has not been taken.

Event Description

Dr.(b)(6) was exposed to fluid from being sprayed under the face shield.

• Brand Name: MASK, FULL FACE W/VELCRO STRAP VENTED FOAM
• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): EMBRACE HEALTHCARE LLC; 100 factory st. ; ste c3; nashua NH 03060
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4617513
• MDR Text Key: 52320685
• Report Number: 1060680-2015-00003
• Device Sequence Number: 1
• Product Code: LYU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2015,03/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 23-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2015
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1