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

Model Number MAM3001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

The mammomark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of the 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.As such, we are submitting this medwatch report.

Event Description

It was reported by the doctor, after procedure, customer works with eviva system.Allergic reaction suspected to the insertion and the material of a marker after vab.The patient has a mild discomfort.Patient complication: allergic reaction.Expected to remove the clip by surgery or vacuum biopsy.

• Brand Name: MAMMOMARK 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 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7754372
• MDR Text Key: 116208457
• Report Number: 3008492462-2018-00057
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other