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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA DISCRETE DRAIN 10FR, END PERFORATED WITH TROCAR STERILE; WOUND DRAIN
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ASPEN SURGICAL PRODUCTS, CALEDONIA DISCRETE DRAIN 10FR, END PERFORATED WITH TROCAR STERILE; WOUND DRAIN Back to Search Results
Model Number 370017
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/26/2022
Event Type  Injury  
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 indicating that the drain tube broke and required surgical intervention to remove the broken piece of the device.This report was filed in our complaint handling system as number (b)(4).
 
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Brand Name
DISCRETE DRAIN 10FR, END PERFORATED 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 Key15203565
MDR Text Key297672943
Report Number1836161-2022-00022
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 Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number370017
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/13/2022
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
Patient Outcome(s) Required Intervention; Other;
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