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

Model Number	MMK0803
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mammomark biopsy site identifier is sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device has not been returned for analysis, which precludes a full investigation.The procedure was completed with the original device.No patient complications.
Event or Problem Description
It was reported by a sales rep that the marker plug broke as it came out of the patient.Dr (b)(6) manually removed the remainder of the plug from the patient.The procedure was completed with the original device.No patient complications.This incident is recorded as complaint number (b)(4).

• Brand Name: MAMMOMARK BIOPSY SITE IDENTIFIER
• 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: 9500999
• Report Number: 3008492462-2019-00052
• Device Sequence Number: 1202679
• Product Code: NEU
• UDI-Device Identifier: 00841911100492
• UDI-Public: (01)00841911100492(17)210201(10)F11931157D
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: MMK0803
• Device Catalogue Number: MMK0803
• Device Lot Number: F11931157D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1