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Dawson Mueller G11386Recalls & reported problems

Cook Incorporated · Dawson-Mueller Drainage Catheter Ultrathane · Class U · Implant

All models of Dawson Mueller (14)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002113862), received between Nov 9, 2017 and Sep 25, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Remove3
  • Gas/Air Leak1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Code Available1
  • No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 25, 2026Difficult to Remove

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50897731 ↗
  • MalfunctionFeb 24, 2023Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THE INNER STIFFENER OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO REMOVE. WHILE PERFORMING A NEPHROSTOMY, THE RADIOLOGIST ATTEMPTED TO REMOVE THE INNER STIFFENER FROM THE CATHETER AND THE ENTIRE CATHETER "BUNCHED UP (CONCERTINA EFFECT)" IN RETURN. ANOTHER CATHETER WAS USED AND PLACED, SUCCESSFULLY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16436502 ↗
  • MalfunctionJan 27, 2022Difficult to Remove; Difficult to Remove

    IT WAS REPORTED THE METAL STIFFENER WITHIN AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER COULD NOT BE WITHDRAWN FROM THE CATHETER. A (B)(6), MALE PATIENT PRESENTED FOR AN ULTRASOUND GUIDED DRAINAGE OF ABDOMINAL WALL COLLECTION. AFTER ADVANCING THE DEVICE INTO PLACE, THE METAL STYLET WOULD NOT DETACH FROM THE CATHETER. A NEW CATHETER WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13371139 ↗
  • InjuryDec 12, 2019Gas/Air Leak; Gas/Air Leak

    IT WAS REPORTED A FEMALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR AN LEFT AXILLA ABSCESS DRAINAGE PROCEDURE. AFTER PLACEMENT, THE OPERATOR NOTICED "THE DRAIN COULD NOT MAINTAIN A SEAL AND SO SUCTION WAS NOT POSSIBLE". THE DRESSING WAS REINFORCED AND THE DEVICE WAS KEPT "INSITU FOR A FEW HOURS". SUCTION WAS NOT ACHIEVED, SO THE DRAIN WAS REPLACED WITH A NEW SIMILAR DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

    Patient problems: No Code Available

    MAUDE report 9460018 ↗
  • MalfunctionNov 9, 2017Leak/Splash

    IT WAS REPORTED THAT THE DEVICE WAS PLACED AND STITCHED TO THE PATIENT WITH THE BAG, LEAKAGE OF BODY FLUID WAS NOTED FROM THE WHITE PLASTIC AREA. THE DEVICE WAS REPLACED.

    Patient problems: No Information

    MAUDE report 7013877 ↗

Other CATHETER, NEPHROSTOMY devices

All CATHETER, NEPHROSTOMY devices →

Sources and updates

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