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

Model Number 4010-01-11-T3

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 08/28/2018

Event Type  Injury  

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 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 hypersensitivity 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 Description

Devicor medical products inc.Received a report from affiliate, devicor medical (b)(4), stating, "placement of the hydromark biopsy site marker was completed on (b)(6) 2018.Physician had confirmed before the operation that the patient was not allergic.Patient presented to the er later at that night with such allergy symptoms as decrease in blood pressure and urticaria.Physician thinks the occurence of the event may have caused by either anesthetic or hydromark".The patient was given loxoprofen by mouth for pain related to the biopsy.Update on august 30, 2018, upon physical exam , the physician confirmed the urticaria resolved.The cause of the reaction was determined to be the xylocaine used in the procedure, not the hydromark.This has been documented in our complaint system as report (b)(4).

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Type of Device: 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 MEDICAL; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california
• Manufacturer Contact: shawna rose ; 300 e. business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7899812
• MDR Text Key: 121436992
• Report Number: 3008492462-2018-00074
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• PMA/PMN Number: K121113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4010-01-11-T3
• Device Catalogue Number: 4010-01-11-T3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization