MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC HYDROMARK BREAST BIOPSY MARKER; TISSUE MARKER

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

The exact date of the initial implant of the marker is unknown (although patient communication indicates 2012).Therefore, the event date has been left blank.Additionally, only the product family has been provide; a specific product code/model has not.Therefore, we are not able to conduct a full investigation and analysis of the device for its potential contribution to the reported event.Patient contacted manufacturer through manufacturer's website.Follow up with treating physician through sales rep indicated that the patient has history of mental illness that may have contributed to recent communication.Additional follow up with the treating physician revealed that the patient contacted them roughly 3 months ago and wanted the clip taken out because she said her body was reacting poorly to it.They advised her to follow up with her general practitioner at that time.Manufacturer communication has also redirected the patient to contact her physician to discuss additional treatment options.The treating physician have not heard from her since the original communication 3 months ago.This was also discussed with our (b)(4).Based on his feedback, it is unlikely that the metal clip is causing a reaction this long after implantation (marker implanted in 2012).At this time, the foreign body reaction is unconfirmed.However, under the abundance of caution, and pursuant to 21 cfr 803 because of the potential serious injury, we are submitting this medwatch report.Not returned to manufacturer.

Event Description

The patient contacted manufacturer via the company website.Statement from that communication: "received markers 2012 infections rare reaction dr claims risks biopsy radiation exposure mri reoccurring cancer type how remove how long expected with leasion.Really need help (b)(6) said rare reaction lesion radio risks where can i get answers.".

• Brand Name: HYDROMARK BREAST BIOPSY MARKER
• Type of Device: TISSUE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): MICRO STAMPING CORPORATION; 12955 starkey rd; suite 3700; largo FL 33773
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 6298643
• MDR Text Key: 66428229
• Report Number: 3008492462-2017-00002
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• PMA/PMN Number: K060769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 01/03/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 02/02/2017
• 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: Unknown
• Patient Sequence Number: 1