MAUDE Adverse Event Report: VITAL CARE INDUSTRIES, LLC; COVER, BARRIER, PROTECTIVE

Catalog Number VPC0548

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Event Description

General purpose probe cover 5" by 48" expires [redacted date], ref# vpc0548, lot# v140222.At the end of kidney biopsy the ultrasound tech noted probe cover not intact.

• Type of Device: COVER, BARRIER, PROTECTIVE
• Manufacturer (Section D): VITAL CARE INDUSTRIES, LLC; 7650 185th st ste c; tinley park IL 60477
• MDR Report Key: 17324551
• MDR Text Key: 319024601
• Report Number: 17324551
• Device Sequence Number: 1
• Product Code: MMP
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPC0548
• Device Lot Number: V140222
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Male