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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; DEVICE, HEMOSTASIS, VASCULAR
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; DEVICE, HEMOSTASIS, VASCULAR Back to Search Results
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The devices were discarded at site.Instead, the customer sent five (5) sterile devices from the same box for evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
The devices were discarded at site.The customer sent five (5) sterile devices from the same box for evaluation.
 
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Type of Device
DEVICE, HEMOSTASIS, VASCULAR
MDR Report Key18248672
MDR Text Key329505242
Report Number3004939290-2023-03513
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2023
Initial Date FDA Received12/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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