MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK; HYDROMARK BREAST BIOPSY SITE MARKER - NON-CE

Model Number	4010-02-15-T3
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the nurse/clinical quality safety specialist, a patient had a reaction to a hydromark marker.The biopsy took place in early (b)(6) 2025.The biopsy was ultrasound guided and used a 14g spring loaded biopsy device.Two core samples were obtained and the marker was placed.The marker applicator was discarded and the lot number was not documented.The next day the patient complained of redness, bruising and pain at the biopsy site.Six days post biopsy, the patient developed a rash and steroid cream was helpful in alleviating the symptom.On (b)(6) 2025 the patient received a diagnostic workup of mammogram and ultrasound.The patient was complaining of itching and skin changes were noted.The radiologist recommended a surgical consultation for removal of the marker.On (b)(6) 2025 the marker was surgically removed.The patient was seen (b)(6) 2026 and it was noted that she was still healing from the surgery.The patient has known allergies of sulfa drugs and penicillin.
Additional Manufacturer Narrative
According to the reporter, the nurse/clinical quality safety specialist, a patient had a reaction to a hydromark marker.The biopsy took place in early (b)(6) 2025.The biopsy was ultrasound guided and used a 14g spring loaded biopsy device.Two core samples were obtained and the marker was placed.The marker applicator was discarded and the lot number was not documented.The next day the patient complained of redness, bruising and pain at the biopsy site.Six days post biopsy, the patient developed a rash and steroid cream was helpful in alleviating the symptom.On (b)(6) 2025 the patient received a diagnostic workup of mammogram and ultrasound.The patient was complaining of itching and skin changes were noted.The radiologist recommended a surgical consultation for removal of the marker.On (b)(6) 2025 the marker was surgically removed.The patient was seen (b)(6) 2026 and it was noted that she was still healing from the surgery.The patient has known allergies of sulfa drugs and penicillin.Please note: the above information was reported verbally by the reporter.The information on the medwatch form differs slightly.The problem occurred after the procedure.The procedure was completed.The patient did experience complications including redness, bruising, pain, itchiness, rash and skin changes.The marker was surgically removed.Good faith efforts were completed and the reporter could not provide lot number.Due to this, the following fields could not be completed: d4 lot #, expiration date, primary udi #, h4 device manufacture date.The device in question was not returned for evaluation.Based on the information currently available the probable root cause is a foreign body reaction.The current instructions for use (ifu) states the following: "although low, a potential for foreign body reaction is possible with the use of hydromark¿ markers.As with any implanted device, the physician should monitor the patient for any signs of irritation, reaction or infection following the surgical procedure and treat accordingly.".

• Brand Name: HYDROMARK
• Common Device Name: HYDROMARK BREAST BIOPSY SITE MARKER - NON-CE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; tijuana, bc 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 24416694
• Report Number: 3008492462-2026-00003
• Device Sequence Number: 16083853
• Product Code: NEU
• UDI-Device Identifier: 00841911100102
• UDI-Public: 00841911100102
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4010-02-15-T3
• Device Catalogue Number: CA000407004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown