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

Lot Number F11814464D

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

Patient had her biopsy and had two titanium clips placed in the area of both biopsies.When radiologist was sent her post mammo pictures, there were no clips to be found.Pt brought back to ultrasound to have x2 more clips placed that were visualized.

• 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: 8992347
• MDR Text Key: 157456447
• Report Number: 8992347
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: F11814464D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1