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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRACOR BREAST TISSUE MARKER

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BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRACOR BREAST TISSUE MARKER Back to Search Results
Catalog Number GMUTC005T
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Unspecified Infection (1930); Pain (1994); Reaction (2414)
Event Date 07/28/2014
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: per the reported event details a marker was deployed into a lymph node. The current ifu states that the gel mark ultracor is intended to radiographically mark breast tissue during a percutaneous biopsy procedure; the marker is not intended for use in lymph nodes. Therefore it is likely that user error contributed to the reported event with the marker deployed in the lymph node. However the definitive root cause for the reported issue with the marker deployed in the breast could not be determined based upon available information. Labeling review: the current instructions for use (ifu) states: warnings: patients with a known hypersensitivity to the materials listed in the device description may suffer an allergic reaction to this implant. Do not use in the presence of infection. Precautions: do not use this product if the sterile barrier has been previously opened or if the package is damaged. 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 Description
It was reported that post breast tissue marker placement in the right axillary lymph node and breast, the patient alleged fever, pain, numbness, infection and lumps on their torso. There was no reported medical intervention provided to treat the alleged symptoms. The current patient status is unknown.
 
Manufacturer Narrative
Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. The definitive root cause for the alleged issue could not be determined based upon available information. It is unknown whether patient and/or procedural issues contributed to the event. 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 Description
It was reported that post breast tissue marker placement in the right axillary lymph node and breast, the patient alleged fever, pain, numbness, infection and a lumps on their torso. There was no reported medical intervention provided to treat the alleged symptoms. The current patient status is unknown.
 
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Brand NameGELMARK ULTRACOR
Type of DeviceBREAST TISSUE MARKER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
INFUS MEDICAL (THAILAND)
706 moo 4
bangpoo ind estate
samutprakarn province 10280
TH 10280
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5553083
MDR Text Key42034529
Report Number2020394-2016-00339
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberGMUTC005T
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2017
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

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