MAUDE Adverse Event Report: HOLOGIC, INC. TRIMARK; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number TRIMARK TD 3612

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Breast Discomfort/Pain (4504)

Event Type  Injury  

Manufacturer Narrative

The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure no dhr review performed.A device history record (dhr) review could not be conducted as the lot/serial number was not provided by the complainant.Or the product is non traceable.

Event Description

It was reported that in (b)(6) 2009 the patient received a trimark marker and after the procedure the patient experience discomfort, pain and her body developed an inflammatory response against it eventually the marker was removed due to the patient pain and discomfort in (b)(6) 2009.No other information is available.

• Brand Name: TRIMARK
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose, alajuela 20102- CRI ; CS 20102 CRI
• MDR Report Key: 12375049
• MDR Text Key: 268461604
• Report Number: 1222780-2021-00240
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRIMARK TD 3612
• Device Catalogue Number: TRIMARK TD 3612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other