MAUDE Adverse Event Report: CARDINAL HEALTH LEVEL 4 SMARTGOWN; GOWN, SURGICAL

Catalog Number 32474

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 04/20/2018

Event Type  Injury  

Event Description

During an open belly procedure, dr has two level 4 gown that had blood soak through the sleeve.The gown was soaked in less than 30 mins with less than 100 cc of blood loss.

• Brand Name: LEVEL 4 SMARTGOWN
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 7457713
• MDR Text Key: 106634298
• Report Number: MW5076698
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 32474
• Device Lot Number: 18AAM024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention