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

Model Number 4010-03-15-T3-SHORT

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Procedure: left breast vab biopsy.Clip did not deploy in lt breast; unknown deployment.

• Brand Name: HYDROMARK
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 east business way fifith floor; cincinnati OH 45241
• MDR Report Key: 7518357
• MDR Text Key: 108392543
• Report Number: 7518357
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

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: Physician
• Device Model Number: 4010-03-15-T3-SHORT
• Device Lot Number: 200042097
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO