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

Model Number	4010-02-15-T3
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Breast Mass (2439)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tech reported one box of mislabeled hydromark.Two clips were deployed in patient; acct would not provide post-images.Investigation was conducted and a quality issue with our current labeling process was identified.Boxes of markers labeled 4010-02-15-t3 associated with lot: f12607207d were confirmed to contain individual packages labeled as 4010-02-15-t4.Imaging of devices from this lot confirmed the markers labeled 4010-02-15-t4 within the 4010-02-15-t3 boxes were 4010-02-15-t3 markers.A recall was initiated (res#: 98843).Customers who received this impacted lot have been notified and were advised to update patient records.No patient complications have been reported as a result of this incident.We are reporting this incident since to date we have not been able to confirm the patient records have been updated.Complaint and vigilance manager called the customer site on (b)(6) 2026 and spoke with the intial reporter to confirm patient records documented the correct marker shape.Initial reporter was not able to confirm over the phone.
Event or Problem Description
Tech reported one box of mislabeled hydromark.Two clips were deployed in patient; acct would not provide post-images.The procedure was completed with another hydromark.No patient complications were noted.

• Brand Name: HYDROMARK
• Common Device Name: HYDROMARK BREAST BIOPSY SITE MARKER
• 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 45241
• MDR Report Key: 25418131
• Report Number: 3008492462-2026-00009
• Device Sequence Number: 18651789
• Product Code: NEU
• UDI-Device Identifier: 10841911100109
• UDI-Public: (01)10841911100109(11)260209(17)290209(10)F12607207D
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K212158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4010-02-15-T3
• Device Lot Number: F12607207D
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES# 98843
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown