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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA BIOPSY SITE MARKER BIOPSY INSTRUMENT

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BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA BIOPSY SITE MARKER BIOPSY INSTRUMENT Back to Search Results
Catalog Number UNK GEL MARK ULTRA
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Swelling (2091)
Event Date 11/23/2018
Event Type  Injury  
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 for the reported device/patient code(s) 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.
 
Event Description
It was reported that approximately seven weeks post breast tissue marker placement, the patient allegedly experienced swelling at the level of the marker. It was further reported the patient required additional intervention. The current patient status is unknown.
 
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 for the reported device/patient code(s) 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.
 
Event Description
It was reported that approximately seven months post breast tissue marker placement, the patient allegedly experienced swelling at the level of the biopsy area due to an alleged foreign body felt at the site. It was further reported the patient required additional intervention, allegedly removing the foreign body at the biopsy area. The current patient status is unknown.
 
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Brand NameGELMARK ULTRA BIOPSY SITE MARKER
Type of DeviceBIOPSY INSTRUMENT
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 Key8453409
MDR Text Key139897721
Report Number2020394-2019-00205
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK GEL MARK ULTRA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2019
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 Treatment Data
Date Received: 03/26/2019 Patient Sequence Number: 1
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