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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA MARKER BREAST TISSUE MARKER Back to Search Results
Model Number GMUEC10GSS
Device Problem Positioning Failure (1158)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/13/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will 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 (expiration date: 12/2021).
 
Event Description
It was reported that during a biopsy procedure, the device allegedly failed to deploy. The patient had excessive bleeding due to multiple time removal. The procedure was completed using another device. The patient's current status was unknown.
 
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Brand NameGELMARK ULTRA MARKER
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
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key11929727
MDR Text Key254310346
Report Number2020394-2021-01164
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGMUEC10GSS
Device Catalogue NumberGMUEC10GSS
Device Lot NumberVTEX00506
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 Received05/22/2021
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: 06/03/2021 Patient Sequence Number: 1
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