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

Model Number	4010-02-15-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	10/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.In accordance with iso 13485:2016 and iso 10993-1 requirements, the hydromark¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contact duration per iso 10993-1.The marker and clip are the only hydomark components classified as having permanent patient contact.Components of the applicator are classified as "limited patient contact" and qualified for the intended use during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanent implantation.The hydromark ifu lists hypersensitivity as a potential adverse reaction.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.In this incident, the sales representative reported that after procedure the patient was experiencing a rash post hydromark clip placement.We reached out to the reporter for additional information and the status of the patient however, they were unable to support our requests.We cannot confirm that our device caused the reported reaction however, we are submitting the report due to the potential adverse reaction.
Event or Problem Description
According to the reporter, the event occurred after the procedure.A patient had an ultrasound biopsy and the hydromark was deployed.There were obvious positive findings/cancer.Patient was fine post procedure, returned home, developed a rash and hives a few hours later.Patient went to the emergency room and was administered benadryl and epinephrine.Patient was discharged and went back to the emergency room with the rash again.
Additional Manufacturer Narrative
The initial report was submitted on 06-nov-2023.The purpose of this follow up report is to correct g6 in the initial report which should have the "initial" box checked.E1 contact information was updated to contain the correct contact name, email, phone number and address.E2 and e3 were updated.In addition, g2 had the incorrect report source box checked and was updated in this follow up report.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: BIOPSY SITE IDENTIFIER
• 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, parque industrial; tijuana, mex 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 18079078
• Report Number: 3008492462-2023-00012
• Device Sequence Number: 20490238
• Product Code: NEU
• UDI-Device Identifier: 10841911100109
• UDI-Public: (01)10841911100109(17)260706(10)F12333425D
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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 Expiration Date: 07/06/2026
• Device Model Number: 4010-02-15-T3
• Device Lot Number: F12333425D
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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