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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM
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ARGON MEDICAL DEVICES SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM Back to Search Results
Model Number 756508025E
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 03/24/2024
Event Type  Injury  
Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
 
Event Description
On the evening of the patient's placement of the catheter, there was leakage from the thread hole of the drainage tube.The catheter was replaced the next day, and the second one also showed leakage.Worried about the patient's potential trauma again, the surgeon first tried to block the thread hole and continued to have the patient wear the catheter.This catheter cannot be charged as the first one has been discarded and the second one is inside the patient's body.
 
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Brand Name
SKATER SINGLE STEP DRAINAGE SET-LOCKING 8F X 25CM
Type of Device
SKATER
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
kelly mayer
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key19177216
MDR Text Key341001367
Report Number0001625425-2024-00994
Device Sequence Number1
Product Code DRE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number756508025E
Device Lot Number11503828
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/25/2023
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;
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