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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET BARD DIMENSION ARTICULATION STONE BACKET/GRASPER 10MM

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C.R. BARD, INC. (COVINGTON) -1018233 BARD® DIMENSION® STONE BASKET BARD DIMENSION ARTICULATION STONE BACKET/GRASPER 10MM Back to Search Results
Model Number 043310
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Injury (2348); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that a few injuries occured perioperatively. When asked why the benefits of using the stone basket product did not outweigh the potential risks, the respondent said "peu de blessures en péri opératoires" meaning "few injuries perioperatively".
 
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Brand NameBARD® DIMENSION® STONE BASKET
Type of DeviceBARD DIMENSION ARTICULATION STONE BACKET/GRASPER 10MM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9469340
MDR Text Key175104216
Report Number1018233-2019-07972
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number043310
Device Catalogue Number043310
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 Received01/12/2020
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: 12/13/2019 Patient Sequence Number: 1
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