Silicone Round Drain 0070230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741049453), received between Jan 4, 2018 and Dec 5, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2019Break; Signal Artifact/Noise; Break

  IT WAS REPORTED THAT THE RADIOPAQUE STRIPE DID NOT PROVIDE ADEQUATE VISIBILITY, AS THEY WERE UNABLE TO SEE WELL ON "LARGE PATIENTS WITH EXTRANEOUS ARTIFACTS."

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9418478 ↗
• InjuryApr 17, 2019Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove

  IT WAS REPORTED THAT UPON REMOVAL OF THE WOUND DRAIN, 27 DAYS AFTER PLACEMENT, THE PHYSICIAN MET RESISTANCE WHEN PULLING ON THE WOUND DRAIN. THE PHYSICIAN ABORTED THE REMOVAL INDICATING THAT IF THE DRAIN WAS PULLED ON ANY HARDER, IT WOULD HAVE BROKEN IN HALF LEAVING A PIECE IN THE PATIENT. THE PATIENT WAS LATER TAKEN TO THE OPERATING ROOM, REQUIRING GENERAL ANESTHETIC AND LAPAROSCOPY TO REMOVE THE DRAIN SURGICALLY.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8524423 ↗
• InjuryFeb 5, 2019Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DEVELOPED POST-OPERATIVE LYMPHOCELE. THE WOUND DRAIN WAS UNABLE TO BE REMOVED BY INTERVENTIONAL RADIOLOGY OR IN THE CLINIC. THE WOUND DRAIN WAS REMOVED UNDER ANESTHESIA WITH AN OPEN ABDOMINAL EXPLORATION. AT THE TIME OF SURGICAL EXPLORATION, A PIECE OF FATTY TISSUE WAS FOUND ADHERED TO THE DISTAL PORTION OF THE DRAIN.

  Patient problems: Patient Problem/Medical Problem; Post Operative Wound Infection

  MAUDE report 8304637 ↗
• MalfunctionFeb 5, 2019Nonstandard Device; Infusion or Flow Problem; Nonstandard Device

  IT WAS REPORTED THAT THE INITIAL INCISION MADE WHEN THE WOUND DRAIN WAS PLACED HAD TO BE STRETCHED OPEN IN ORDER FOR THE WOUND DRAIN TO BE REMOVED. NO DEVICE BREAKAGE OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8304635 ↗
• MalfunctionFeb 5, 2019Nonstandard Device; Physical Resistance/Sticking; Nonstandard Device

  IT WAS REPORTED THAT THE WOUND DRAIN WAS ONLY ABLE TO BE REMOVED A FEW CENTIMETERS BEFORE SIGNIFICANT RESISTANCE WAS MET. THE PATIENT HAD TO BE REPOSITIONED AND MULTIPLE ATTEMPTS HAD TO BE MADE TO REMOVE THE DRAIN BEFORE IT WAS ULTIMATELY REMOVED. THE PATIENT EXPERIENCED PAIN DURING THE PROCESS. NO DEVICE BREAKAGE OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Pain

  MAUDE report 8304560 ↗
• MalfunctionJan 4, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE FOUND IN THE PACKAGING OF THE DEVICE.

  Patient problems: No Information

  MAUDE report 7165740 ↗