MAUDE Adverse Event Report: DEVICOR MAMMOMARK; BREAST TISSUE MARKER CLIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 03/12/2012

Event Type  Injury  

Event Description

A routine screening resulting biopsy marker clip asa risk recalls possible rare reaction.

• Brand Name: MAMMOMARK
• Type of Device: BREAST TISSUE MARKER CLIP
• Manufacturer (Section D): DEVICOR; cincinnati OH
• MDR Report Key: 6349217
• MDR Text Key: 68104620
• Report Number: MW5068009
• Device Sequence Number: 1
• Product Code: NEU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: TEA
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 79