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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER

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ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER Back to Search Results
Model Number FJ.120096
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hematoma (1884)
Event Type  Injury  
Event Description
On (b)(6) 2020, the patient underwent a filter implantation procedure. On (b)(6) 2020, a ct scan found no abnormality in the patient. On (b)(6) 2020, the patient complained of back pain. A ct scan revealed a retroperitoneal hematoma. Whether perforation occurred or not was unknown because an angiography was not performed. There are no external factors found which might cause perforation, and the influence of the treated tumor was unlikely. On (b)(6) 2020, it was planned to transfer the patient to the national cerebral and cardiovascular center. Because dr. (b)(6) of the initial hospital could not perform the filter retrieval procedure due to missing the surgical backup section. Patient's condition after the operation: the patient is treated with observation.
 
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Brand NameALN OPTIONAL VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
ALN IMPLANTS CHIRURGICAUX
589 chemin du niel
bormes les mimosas, 83230
FR 83230
Manufacturer Contact
severine joly
589 chemin du niel
bormes les mimosas, 83230
FR   83230
MDR Report Key10981730
MDR Text Key220646372
Report Number3007080617-2020-00005
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K163699
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Remedial Action Patient Monitoring
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFJ.120096
Device Lot Number110917
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 Received10/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/10/2020 Patient Sequence Number: 1
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