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	12/14/2022
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.The instruction for use and deployment guide, provided with the device, must be followed to avoid the applicator from shearing.In accordance with iso 13485:2016and iso 10993-1 requirements, the hydromark¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contactduration per iso 10993-1.The collagen marker and titanium clip are the only mammomark components classified as havingpermanent patient contact." components of the applicator are classified as "limited patient contact" and qualified for the intendeduse during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanentimplantation.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.It was reported by the representantive that a 38-year-old patient had an allergic reaction after the hydromark t3 marker was deployed.The patient received hydromark t3 and is in icu from having an anaphylactic reaction after the procedure had occured.The patients only known allergy is penicillin.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 medical attention received.
Event or Problem Description
The representative reported a 38-year-old patient had an allergic reaction after the hydromark t3 marker was deployed.The patient received hydromark t3 lot and is in icu from having an anaphylactic reaction.The patients only known allergy is penicillin.
Additional Manufacturer Narrative
The initial report was submitted on 13-jan-2023.The purpose of this follow up report is to correct g6 in the initial report which should have the "initial" box checked and d4 expiration date was corrected.In addition, e1 contact information was updated to contain the correct contact name and email.The phone number of the contact was added.

• 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 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 16158362
• Report Number: 3008492462-2023-00001
• Device Sequence Number: 15193144
• Product Code: NEU
• UDI-Device Identifier: 10841911100109
• UDI-Public: (01)10841911100109(17)250804(10)F12233446D
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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: 08/04/2025
• Device Model Number: 4010-02-15-T3
• Device Lot Number: F12233446D
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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