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

Model Number 40100315T3SHOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/05/2018

Event Type  malfunction  

Event Description

Atec clip was inserted into the right breast and clicked to deploy.Patient then went to mammogram for a follow-up mammogram to show clip placement.No clip was seen so she had to come back to ultrasound and have her band aids and steri strips removed to insert a core clip, which worked.

• 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: 7453697
• MDR Text Key: 106302638
• Report Number: 7453697
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 40100315T3SHOR
• Device Lot Number: 200038945
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 62 YR
• Patient Weight: 135