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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA 10FR DRAIN ROUND XTRA FLUTED WITH TROCAR STERILE; WOUND DRAIN
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ASPEN SURGICAL PRODUCTS, CALEDONIA 10FR DRAIN ROUND XTRA FLUTED WITH TROCAR STERILE; WOUND DRAIN Back to Search Results
Model Number 322227
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 03/16/2021
Event Type  malfunction  
Manufacturer Narrative
No further information is available on the product at this time.No sample or photographic evidence was provided for review.However, if any additional relevant information is identified, the relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the end user indicating that the device was not functioning as intended.The item was in use.No injury or death was reported.This report was filed in our complaint handling system as number (b)(4).
 
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Brand Name
10FR DRAIN ROUND XTRA FLUTED WITH TROCAR STERILE
Type of Device
WOUND DRAIN
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 Key11655144
MDR Text Key247314584
Report Number1836161-2021-00017
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number322227
Device Lot Number236012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2021
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 Sequence Number1
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