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

Model Number	4010-04-09-T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the event occurred after the procedure and the patient had an allergic reaction to a hydromark open-coil titanium marker.The reporter did not have the product code or the lot number of the marker used.On (b)(6) 2025, about 3 hours post marker placement, the patient developed hives and felt hot.The patient went to the emergency room and was treated with epinephrine.The marker was surgically removed two days later on (b)(6) 2025.The patient's symptoms are resolving.The patient is allergic to latex, although no latex was used during the biopsy.The biopsy device being used was a hologic brevera 9g needle.This was a stereotactic guided biopsy.Complaint device: -4010-04-09-t3 -lot #f12526208d or lot# f12509102d-account does not know which lot was used.The procedure was completed with these devices.
Additional Manufacturer Narrative
According to the reporter, the event occurred after the procedure and the patient had an allergic reaction to a hydromark open-coil titanium marker.The reporter did not have the product code or the lot number of the marker used.On (b)(6) 2025, about 3 hours post marker placement, the patient developed hives and felt hot.The patient went to the emergency room and was treated with epinephrine.The marker was surgically removed two days later on (b)(6) 2025.The patient's symptoms are resolving.The patient is allergic to latex, although no latex was used during the biopsy.The biopsy device being used was a hologic brevera 9g needle.This was a stereotactic guided biopsy.Complaint device: -4010-04-09-t3 -lot #f12526208d or lot# f12509102d-account does not know which lot was used.The procedure was completed with these devices.The device in question was not returned to the manufacturer for evaluation.Based on the information currently available, it is most likely that the reported adverse event was related to the patient's underlying condition.Note: d4 expiration date, h4 device manufacturer date were not entered as two possible lot numbers were provided by the customer.The device history records were reviewed for both lot numbers and no issues were found.

• 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: 23310763
• Report Number: 3008492462-2025-00026
• Device Sequence Number: 12009199
• Product Code: NEU
• UDI-Device Identifier: 00841911100195
• UDI-Public: (01)00841911100195(11)250519(17)280519(10)F12526208D
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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: 4010-04-09-T3
• Device Catalogue Number: CA000408002
• Device Lot Number: F12526208D / F12509102D
• 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: 09/18/2025
• Initial Report FDA Received Date: 10/16/2025
• 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; Hospitalization; Required Intervention
• Patient Sex: Unknown