MAUDE Adverse Event Report: EVERWELL MEDICAL SUPPLY, LLC N/A; GOWN, SURGICAL

Lot Number 202011004

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  malfunction  

Event Description

Physicians and physician assistants are claiming blood is getting through the surgical gowns.

• Brand Name: N/A
• Type of Device: GOWN, SURGICAL
• Manufacturer (Section D): EVERWELL MEDICAL SUPPLY, LLC; 19400 san jose avenue; city of industry CA 91748
• MDR Report Key: 11700363
• MDR Text Key: 246483101
• Report Number: 11700363
• Device Sequence Number: 1
• Product Code: FYA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 202011004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1