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

Model Number	4010-02-15-T4
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	12/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the patient experienced an acute allergic reaction immediately following hydromark implantation, presenting with tongue and throat edema and localized redness at the site.Emergency response was initiated, and the patient was transported to the emergency room (er).The patient was given epinephrine in the breast center and again later that evening in the er.Symptoms resolved within hours but recurred approximately 12 hours later and on two subsequent occasions.The patient was prescribed corticosteroids to manage the symptoms.No marker removal is planned as the lesion is benign.Additional information: patient has alpha-gal syndrome (ags) and inquired whether polyethylene glycol (peg) contains mammalian-derived components.The marker was implanted by direct puncture.The marker applicator was discarded after use.The problem occurred after the procedure.The procedure was completed with the reported marker.
Additional Manufacturer Narrative
According to the reporter, the patient experienced an acute allergic reaction immediately following hydromark implantation, presenting with tongue and throat edema and localized redness at the site.Emergency response was initiated, and the patient was transported to the emergency room (er).The patient was given epinephrine in the breast center and again later that evening in the er.Symptoms resolved within hours but recurred approximately 12 hours later and on two subsequent occasions.The patient was prescribed corticosteroids to manage the symptoms.No marker removal is planned as the lesion is benign.Additional information: patient has alpha-gal syndrome (ags) and inquired whether polyethylene glycol (peg) contains mammalian-derived components.The marker was implanted by direct puncture.The marker applicator was discarded after use.The problem occurred after the procedure.The procedure was completed with the reported marker.Additional good faith effort response noted that the marker was not removed from the patient.A review of the device's materials and specifications verified that no polyethylene glycol (peg), that contain mammalian-derived components, are used in the implanted device.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: 24200150
• Report Number: 3008492462-2026-00001
• Device Sequence Number: 17520101
• Product Code: NEU
• UDI-Device Identifier: 00841911100119
• UDI-Public: (01)00841911100119(11)250910(17)280910(10)F12537130D
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

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-T4
• Device Catalogue Number: CA000407005
• Device Lot Number: F12537130D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2025
• 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