MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA; MARKER, RADIOGRAPHIC, IMPLANTABLE

Catalog Number	STAR0831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wheal(s) (2241)
Date of Event	07/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The star0831 biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location.The procedure was completed without incident at that time.The patient developed hives several weeks after the procedure.A patch test was conducted with the biopsy site identifier and the patient tested positive.The patient, in counsel with her doctor, is contemplating explantation but at the time of this report the device remains implanted.
Event or Problem Description
The sales rep reported that the patient developed an allergic reaction (hives) several weeks after a biopsy site identifier placement procedure.

• Brand Name: MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• MDR Report Key: 6121826
• Report Number: 2134494-2016-00003
• Device Sequence Number: 10816068
• Product Code: NEU
• UDI-Device Identifier: 00858015005325
• UDI-Public: 00858015005325
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K100994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2016

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
• Operator of Device: No Information
• Device Expiration Date: 03/19/2021
• Device Catalogue Number: STAR0831
• Device Lot Number: 1601008A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other