MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC LOCALIZER TAG READER; MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Problem (1384)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2021

Event Type  Injury  

Event Description

During a right breast lumpectomy with a removal of a tag and use a handheld device reader to locate the device.The reader could not locate the tag.The surgeon hand manipulated to feel the tag where placed.Potentially, after placement of the tag and after the lumpectomy, it was determined that the tag was broken inside the patient.Fda safety report id# (b)(4).

• Brand Name: HOLOGIC LOCALIZER TAG READER
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC. ; marlboro MA 01752
• MDR Report Key: 11806249
• MDR Text Key: 250257664
• Report Number: MW5101280
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/07/2021

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 122