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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, there was an allergic reaction to the marker 4010-02-15-t4.The doctor had a patient experience an allergic reaction 24 hours after an ultrasound-guided biopsy using an alcohol swab, lidocaine 1%, and adhesive dressing.The patient experienced hives all over her body which lasted for about 72 hours and resolved with prednisone and zyrtec.The marker remains in the patient's breast.The problem occurred after the procedure.The procedure was completed with the reported marker.
Additional Manufacturer Narrative
According to the reporter, there was an allergic reaction to the marker 4010-02-15-t4.The doctor had a patient experience an allergic reaction 24 hours after an ultrasound-guided biopsy using an alcohol swab, lidocaine 1%, and adhesive dressing.The patient experienced hives all over her body which lasted for about 72 hours and resolved with prednisone and zyrtec.The marker remains in the patient's breast.The problem occurred after the procedure.The procedure was completed with the reported marker.The device was not returned for evaluation.The root cause was traced to non-device related factors.Based on the information available it is most likely the adverse event was related to the patient condition.

• 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 ; 5138649047
• MDR Report Key: 21643361
• Report Number: 3008492462-2025-00011
• Device Sequence Number: 15369099
• Product Code: NEU
• UDI-Device Identifier: 00841911100119
• UDI-Public: (01)00841911100119(11)240918(17)270918(10)F12439348D
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212158
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2025

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: F12439348D
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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