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

Model Number	4010-02-15-T4
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 week, and be permanently visible by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of a root cause at this time.However, this failure mode has been identified in the risk management file for the effects of potential foreign body reaction with a potential for injury to the patient and/or user.Follow up medical intervention may be necessary.Although it could not be concluded that our device caused or contributed to this event, through evaluation by our medical advisor on similar events, this has been determined to be reportable pursuant to 21 cfr 803.
Event or Problem Description
Devicor medical products, inc.Received a report from the user facility stating, a butterfly shaped titanium hydromark marker was placed in (b)(6) 2018.The patient complained of pain since that time and requested removal of the marker.The clip was removed (b)(6) 2019.This has been documented in our system as record # (b)(4).

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: BIOPSY SITE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 8897042
• Report Number: 3008492462-2019-00040
• Device Sequence Number: 16548644
• Product Code: NEU
• UDI-Device Identifier: 00841911101482
• UDI-Public: (01)00841911101482(17)210311(10)200044907
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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: 03/11/2021
• Device Model Number: 4010-02-15-T4
• Device Catalogue Number: 4010-02-15-T4
• Device Lot Number: 200044907
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention