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

Model Number MMK0803

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

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 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
• Type of Device: BIOPSY SITE MARKER
• 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, 22440 ; MX 22440
• Manufacturer Contact: jack cummings ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 9500999
• MDR Text Key: 219763338
• Report Number: 3008492462-2019-00052
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911100492
• UDI-Public: (01)00841911100492(17)210201(10)F11931157D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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