MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES; MASK, SURGICAL

Model Number AT71235, AT752005

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/26/2018

Event Type  malfunction  

Event Description

Surgical mask has a metal piece on both internal sides of the mask that caused facial lacerations of some staff during normal wear for invasive procedures.We are pulling the product from our inventory.A design change to mitigate the risk of injury to clinical staff has been requested.Per hospital, informed product was being removed from clinical departments and inventory.

• Brand Name: LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES
• Type of Device: MASK, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7933444
• MDR Text Key: 122645069
• Report Number: 7933444
• Device Sequence Number: 1
• Product Code: FXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AT71235, AT752005
• Device Catalogue Number: AT71235, AT752005
• Device Lot Number: 1071235, 1752005
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other