MAUDE Adverse Event Report: CELEROMARK BIOPSY SITE MARKERS; BREAST BIOPSY MARKER

Model Number CELEROMARK

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Reaction (2414)

Event Date 01/07/2017

Event Type  Injury  

Manufacturer Narrative

Lot number not provided by the complainant therefore the expiration date is not known.The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Lot number not provided by the complainant therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted as the lot number was not provided by the complainant.(b)(4).

Event Description

It was reported a physician placed a celeromark during a celero for breast biopsy procedure on (b)(6) 2016.Approximately a week later the patient reported with "systemic reaction (rash of the body).The physician removed the marker on (b)(6) 2017.The patient has not contacted the radiology center since the removal.No additional information is forthcoming.

Manufacturer Narrative

(b)(4).

• Brand Name: CELEROMARK BIOPSY SITE MARKERS
• Type of Device: BREAST BIOPSY MARKER
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6299580
• MDR Text Key: 66436895
• Report Number: 1222780-2017-00018
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: No Information
• Device Expiration Date: 09/07/2017
• Device Model Number: CELEROMARK
• Device Lot Number: 16J07R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CELEROMARK HANDPIECE: LOT# UNK
• Patient Outcome(s): Required Intervention