DryDoc Vacuum Station DD15Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00801741151781), received between Jul 17, 2018 and Jan 17, 2023 — classified as 17 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Increase in Suction” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DRYDOC SYSTEM SMELL LIKE FIRE WHEN IT WAS RUNNING THEN STOPPED TURNING ON . IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PUREWICK PRODUCTS FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183537 ↗
• InjuryJun 20, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS NOT USING THE DRYDOC DEVICE BECAUSE THE PATIENT EXPERIENCED URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12030397 ↗
• MalfunctionJul 22, 2020Stretched; Increase in Suction; Increase in Suction

  IT WAS REPORTED THAT WHILE REMOVING THE WICK, THE VACUUM SUCTION CAUSED THE PATIENT'S SKIN TO PULL APART AND RESULTED IN BLEEDING. ALSO PATIENT SAID THE HOSES STRETCH OUT AFTER USE. NO MEDICAL INTERVENTION WAS REPORTED

  Patient problems: Patient Problem/Medical Problem; Skin Tears

  MAUDE report 10307309 ↗
• MalfunctionJul 16, 2020Increase in Suction; Appropriate Device Problem Term/Code Not Available; Increase in Suction

  IT WAS REPORTED THAT THE PATIENT NO LONGER USING THE PURE WICK. ALSO, STATED THAT THE VACUUM SEEMED TO CAUSE DAMAGE TO THE TISSUE OF THE VULVA. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 10283100 ↗
• MalfunctionMay 1, 2020Increase in Suction; Fluid/Blood Leak; Increase in Suction; Defective Device

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE WICKS HAVE NOT BEEN WORKING; THERE HAS BEEN LEAKING AND SPILLING ISSUES; IN ADDITION THEY STATED SOMETIMES URINE WAS NOT BEING COLLECTED IN CONTAINER AND SOMETIMES IT SUCTIONS MORE THAN OTHER TIMES. THE PUREWICK WAS PLACED AS SEEN IN MANUAL, AND THERE WAS NO BLOCKAGE OR BUILD UP IN THE 70 INCH PATIENT HOSE. A WATER CUP TEST WAS CONDUCTED AND IT PASSED.

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

  MAUDE report 10017958 ↗
• InjuryApr 18, 2020Suction Problem; Biocompatibility; Biocompatibility

  IT WAS REPORTED THE NURSES IN THE HOSPITAL DID NOT KNOW THE PROPER SUCTION AND IT GAVE HER A WOUND. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Skin Irritation

  MAUDE report 9975699 ↗
• MalfunctionApr 6, 2020Labelling, Instructions for Use or Training Problem; Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT RECEIVED A PUREWICK WITH NO EXPLANATION ON HOW TO USE THE MACHINE, AND DIDN'T HAVE PRICING INFORMATION.

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

  MAUDE report 9928545 ↗
• InjuryApr 6, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT THE AUTHORIZED PERSON FOR THE PATIENT STATED THE PATIENT DEVELOPED A UTI WHILE USING THE SYSTEM. THEY ARE NOT SURE IF IT WAS FROM SYSTEM.

  Patient problems: Urinary Tract Infection

  MAUDE report 9928386 ↗
• MalfunctionFeb 19, 2020Misassembled; Failure to Power Up; Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID THERE WAS A WIRE WITH A RED CAP EXPOSED ON THE BACK OF THE DRYDOC. PER FOLLOW UP WITH CUSTOMER ON (B)(6) 2020, THEY STATED THE DEVICE WOULD NOT POWER ON.

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

  MAUDE report 9729653 ↗
• MalfunctionFeb 7, 2020Labelling, Instructions for Use or Training Problem; Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE A MANUAL WITH THE PUREWICK DRYDOC SYSTEM.

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

  MAUDE report 9684065 ↗
• MalfunctionJan 31, 2020Increase in Suction; Suction Problem; Increase in Suction

  IT WAS REPORTED THAT THE PATIENT SAID SHE¿S BEEN HAVING PROBLEMS WITH THE PUREWICK. SHE SAID THERE ARE SPOTS OF BLOOD ON THE WICK, HER LABIA FEELS ABRADED AND SORE, AND IT FEELS LIKE THE WICK IS SUCTIONING ON HER LABIA, PINCHING IT. SHE HAS SPOKEN WITH HER DOCTOR ABOUT THIS. NO MEDICAL INTERVENTION REPORTED. PER FOLLOW UP ON 21JAN2020, THE CUSTOMER FELT LIKE THE SUCTION WAS HIGHER ON THE DRY DOC, SHE HAS NOW SWITCHED TO SILICONE WICKS.NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Abrasion; No Consequences Or Impact To Patient

  MAUDE report 9654832 ↗
• MalfunctionJan 21, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE PATIENT SAID SHE¿S BEEN HAVING PROBLEMS WITH THE PUREWICK. SHE SAID THERE ARE SPOTS OF BLOOD ON THE WICK, HER LABIA FEELS ABRADED AND SORE, AND IT FEELS LIKE THE WICK IS SUCTIONING ON HER LABIA, PINCHING IT. SHE HAS SPOKEN WITH HER DOCTOR ABOUT THIS. NO MEDICAL INTERVENTION REPORTED. PER FOLLOW UP ON (B)(6) 2020, THE CUSTOMER SWITCHED TO SILICONE WICKS, AND SHE FEELS LIKE THE SUCTION WAS HIGHER.

  Patient problems: Abrasion

  MAUDE report 9612322 ↗
• InjuryDec 20, 2019Suction Problem; Decrease in Suction; Fluid/Blood Leak; Suction Problem

  IT WAS REPORTED THAT THE PATIENT SAID SHE WAS NOT HAPPY WITH THE PUREWICK. SHE SAID SHE FOLLOWED THE DIRECTIONS TO THE LETTER, BUT SHE WAS STILL WAKING UP WET EVERY MORNING. SHE SAID SHE HAD AN INFECTION AT THE MOMENT, AND IT WAS UNKNOWN WHAT TYPE OF INFECTION THE PATIENT EXPERIENCED. IT WAS LATER REPORTED ON (B)(6)2019 , THE PATIENT'S DAUGHTER SAID THAT THERE WAS LOW SUCTION AND THAT MADE THE LEAK OCCUR.

  Patient problems: Unspecified Infection

  MAUDE report 9503144 ↗
• MalfunctionDec 16, 2019Increase in Suction; Increase in Suction; Suction Problem

  IT WAS REPORTED THAT THE PATIENT SAID SHE WAS GETTING SORE SPOTS, THE SUCTION WAS HURTING HER, AND SHE WAS GETTING A PINCHING SENSATION. SHE SAID SHE USED ONE WICK FOR 24 HOURS, AND THE REP ADVISED HER IT WAS RECOMMENDED SHE CHANGE THE WICK AFTER 8-12 HOURS OF USE. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 9474616 ↗
• MalfunctionDec 16, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT AND HER DAUGHTER STATED THAT THEY HAVE REQUESTED A PUREWICK DRYDOC MANUAL SEVERAL TIMES AND STILL HAVE NOT RECEIVED ONE. THE DAUGHTER IS VERY UPSET AND UNHAPPY. PER FOLLOW UP CALL ON 3DEC2019, THE CUSTOMER STATED THEY NEVER RECEIVED THE MANUAL FOR THEIR DRY DOC.

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

  MAUDE report 9474614 ↗
• InjuryNov 11, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICE CAUSED THE SKIN ON THE PATIENT'S LABIA TO COME OFF. IT WAS STATED THAT THE PATIENT IS CURRENTLY IN THE HOSPITAL FOR THE ISSUE.

  Patient problems: Abrasion; Peeling; Tissue Breakdown

  MAUDE report 9306575 ↗
• InjuryOct 16, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT¿S SON STATED HIS MOM GOT UTI FROM THE DRYDOC. PER FOLLOW UP CALL ON 04OCT2019, THE PATIENT RECEIVED CIPRO AND DOXY AS TREATMENT FOR THE UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 9198945 ↗
• MalfunctionOct 15, 2019Increase in Suction

  IT WAS REPORTED THAT THE PATIENT SAID THE SUCTION WAS TOO STRONG AND SOMETIMES PAINFUL.

  Patient problems: Pain

  MAUDE report 9191001 ↗
• MalfunctionOct 15, 2019Increase in Suction; Adverse Event Without Identified Device or Use Problem; Increase in Suction

  IT WAS REPORTED THAT THERE WAS A SKIN BREAKDOWN WHILE USING THE DRY DOC.

  Patient problems: No Consequences Or Impact To Patient; Tissue Breakdown

  MAUDE report 9190983 ↗
• InjuryOct 4, 2019Increase in Suction; Suction Problem; Increase in Suction

  IT WAS REPORTED THAT THE DEVICE HAD TOO MUCH SUCTION CAUSING A SKIN BREAKDOWN.

  Patient problems: Patient Problem/Medical Problem; Tissue Breakdown

  MAUDE report 9157207 ↗
• MalfunctionOct 1, 2019Increase in Suction; Adverse Event Without Identified Device or Use Problem; Increase in Suction

  IT WAS REPORTED THAT SOME OF THE PATIENTS DEVELOPED ULCERS IN THEIR PRIVATE AREAS WHEN THE SUCTION WAS HIGH. PER EMAIL RECEIVED ON 23-SEP-2019, THERE WERE 2 DEVICES WITH THIS ISSUE AND THERE ARE NO DEVICES AVAILABLE FOR RETURN.THE PATIENTS DID NOT RECEIVE MEDICATION FOR THE ULCERS.

  Patient problems: Skin Tears; Ulcer

  MAUDE report 9141448 ↗
• MalfunctionSep 20, 2019Break; Break

  IT WAS REPORTED BY THE SURGICAL TEAM THAT UPON REMOVAL OF THE NG TUBE, IT WAS OBSERVED THAT THE DISTAL HOLE HAD A CRACK IN IT AND THE TUBE WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9098664 ↗
• MalfunctionSep 17, 2019Crack; Material Twisted/Bent

  IT WAS REPORTED BY THE SURGICAL TEAM THAT UPON REMOVAL OF THE NG TUBE, IT WAS OBSERVED THAT THE DISTAL HOLE HAD A CRACK IN IT AND THE TUBE WAS BENT.

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

  MAUDE report 9078409 ↗
• MalfunctionSep 11, 2019Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER LEAKED.

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

  MAUDE report 8992427 ↗
• MalfunctionSep 5, 2019Increase in Suction; Suction Problem; Increase in Suction

  IT WAS REPORTED THAT THE DRY DOC DEVICE SUCTION WAS TO STRONG AND CAUSED THE PATIENT SOME PAIN AND DISCOMFORT.

  Patient problems: Discomfort; Pain

  MAUDE report 8964704 ↗