MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GEL MARK ULTRA BREAST TISSUE MARKER; IMPLANTABLE CLIP

Model Number	GMUEC10GSS
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	10/01/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
It was reported that post placement of a breast tissue marker, the patient allegedly had episodes of idiopathic urticaria.There was no reported patient injury.

• Brand Name: GEL MARK ULTRA BREAST TISSUE MARKER
• Common Device Name: IMPLANTABLE CLIP
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7438655
• Report Number: 2020394-2018-00400
• Device Sequence Number: 1160608
• Product Code: FZP
• UDI-Device Identifier: 00801741031854
• UDI-Public: (01)00801741031854
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GMUEC10GSS
• Device Catalogue Number: GMUEC10GSS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1