M-Drain D12010035Recalls & reported problems
Mermaid Medical A/S · The Percutaneous Drainage Catheter with hydrophilic coating is used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material which is radiopaque for X-rays. The distal end of catheter contains a “J” or a self-retaining pigtail and drainage holes. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15711055001103), received between Apr 20, 2021 and Apr 20, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Crack1
- Gas/Air Leak1
- Suction Problem1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2021Crack; Suction Problem; Gas/Air Leak
A (B)(6) PATIENT, ONE WEEK POSTOPERATIVE FROM LAPAROSCOPIC HYSTERECTOMY WAS ADMITTED THE EMERGENCY DEPARTMENT WITH INCREASED TEMPERATURE AND ABDOMINAL PAIN. IN CAT SCAN, A M-DRAIN MULTI-PURPOSE PERCUTANEOUS ABDOMINOTHORACIC DRAINAGE CATHETER WAS PLACED IN THE PELVIS. ACCORDING TO THE PHYSICIAN, THE M-DRAIN CATHETER HAD AN AIR LEAK FROM A HOLE IN THE TOP THIRD PROXIMAL END OF TUBING OR A CRACK AT THE HUB. THE M-DRAIN CATHETER WOULD NOT HOLD SUCTION. CATHETER REMOVED AND ANOTHER ONE INSERTED WITHOUT FURTHER ISSUES. NO KNOWN HARM TO PATIENT AND DISCHARGED HOME THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 11692733 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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