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 Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, there was an allergic reaction to (1) 4010-02-15-t3.The patient experienced an allergic reaction 6 hours after an ultrasound-guided biopsy using the eviva biopsy machine.She arrived at the emergency room via emergency medical services with the following symptoms: syncope, hives, hypotension 60s/40s, altered mental status changes, pale in color, diaphoretic weakness.The patient was treated with an epinephrine intravenous (iv) drip and removed after six hours.The marker was surgically removed five days later.The issue occurred after the procedure.The procedure was completed with this device prior to issue.The patient experienced a complication, explained as an allergic reaction.Surgical removal of marker was performed to solve the patient complication.
Additional Manufacturer Narrative
According to the reporter, there was an allergic reaction to (1) 4010-02-15-t3.The patient experienced an allergic reaction 6 hours after an ultrasound-guided biopsy using the eviva biopsy machine.She arrived at the emergency room via emergency medical services with the following symptoms: syncope, hives, hypotension 60s/40s, altered mental status changes, pale in color, diaphoretic weakness.The patient was treated with an epinephrine intravenous (iv) drip and removed after six hours.The marker was surgically removed five days later.The issue occurred after the procedure.The procedure was completed with this device prior to issue.The patient experienced a complication, explained as an allergic reaction.Surgical removal of marker was performed to solve the patient complication.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: 21645020
• Report Number: 3008492462-2025-00012
• Device Sequence Number: 7614870
• Product Code: NEU
• UDI-Device Identifier: 00841911100102
• UDI-Public: (01)00841911100102(11)240814(17)270814(10)F12434232D
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K212158
• 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: Other Health Care Professional
• 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-T3
• Device Catalogue Number: CA000407004
• Device Lot Number: F12434232D
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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: Hospitalization
• Patient Sex: Unknown