MAUDE Adverse Event Report: HOLOGIC, INC. CELEROMARK BIOPSY SITE MARKERS; BREAST BIOPSY MARKER

Model Number CELEROMARK

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

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Lot number not provided by the complainant therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.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.Reference internal complaint (b)(4).

Event Description

It was reported by the patient who biopsy marker had implanted in (b)(6) 2015.The patient claims allergic reaction, not diagnosed by physician as yet.There was a rash on the breast skin tissue.We have been unable to obtain additional information surrounding this event.

• Brand Name: CELEROMARK BIOPSY SITE MARKERS
• Type of Device: BREAST BIOPSY MARKER
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6980773
• MDR Text Key: 90395114
• Report Number: 1222780-2017-00259
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CELEROMARK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other