MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number 4010-02-15-T4

Device Problem Component Missing (2306)

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

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Patient had a breast biopsy with clip placement.Performed clip placement, but clip was not seen on mammogram after the procedure.

• Brand Name: HYDROMARK
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8463789
• MDR Text Key: 140349081
• Report Number: 8463789
• Device Sequence Number: 1
• Product Code: NEU
• 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: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4010-02-15-T4
• Device Lot Number: F11828515D
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1