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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD ALLAN VESSEL LOOP MAXI BLUE NON-STERILE
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ASPEN SURGICAL PRODUCTS, CALEDONIA RICHARD ALLAN VESSEL LOOP MAXI BLUE NON-STERILE Back to Search Results
Model Number 390290
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 03/03/2020
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.
 
Event Description
Aspen surgical received a report from the distributor indicating that a breakage in a vessel loop occurred during a procedure.The incident occurred at the end user.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).
 
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Brand Name
RICHARD ALLAN VESSEL LOOP MAXI BLUE NON-STERILE
Type of Device
VESSEL LOOP
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key9903252
MDR Text Key194303302
Report Number1836161-2020-00019
Device Sequence Number1
Product Code KDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number390290
Device Lot Number202360
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2020
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 Sequence Number1
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