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

Model Number 4010-02-15-T3

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 01/09/2019

Event Type  malfunction  

Event Description

During a breast biopsy, a butterfly clip did not deploy.Noted in breast after review of post mammogram.Patient was re-clipped with open coil clip.

• 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: 8292394
• MDR Text Key: 134587951
• Report Number: 8292394
• 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: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4010-02-15-T3
• Device Catalogue Number: 4010-02-15-T3
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2019
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 01/31/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1