V.A.C.® GRANUFOAM™ M8275052/5 M8275052/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00849554002098), received between Apr 2, 2020 and Oct 16, 2025 — classified as 27 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (9 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: THE V.A.C.® GRANUFOAM¿ DRESSING WAS TOO LONG, AND SHE HAD TO CLIP IT TO HER PANTS. THE TUBING DETACHED FROM HER PANTS AND ENTANGLED AROUND THE TIRE OF HER HUSBAND¿S CAR CAUSING HER TO FALL. AS A RESULT OF THE FALL, SHE SUSTAINED A LACERATION TO HER FOREHEAD THAT REQUIRED SUTURES AND SUFFERED A FRACTURED SHOULDER. SHE SUBSEQUENTLY UNDERWENT SURGICAL INTERVENTION FOR THE SHOULDER INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2025, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER C21005V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Bone Fracture(s); Laceration(s)

  MAUDE report 23314735 ↗
• InjuryJun 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: ON (B)(6) 2025, V.A.C.® THERAPY WAS REMOVED DUE TO PIECES OF FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING FOUND IN THE WOUND BED. SHE EXPLAINED THAT SHE WILL REQUIRE SURGICAL DEBRIDEMENT TO REMOVE THE PIECES. PER THE PHYSICIAN, SHE WILL REQUIRE SURGICAL DEBRIDEMENT ON (B)(6) 2025 TO REMOVE THE PIECES AND V.A.C.® THERAPY WILL BE REAPPLIED. ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE GENERAL SURGEON: THERE WERE VERY SMALL FRAGMENTS OF V.A.C.® GRANUFOAM¿ DRESSING FOUND AT THE BASE OF THE WOUND. DUE TO LIMITED VISIBILITY, SURGICAL INTERVENTION WAS REQUIRED TO ENSURE ALL PIECES WERE COMPLETELY REMOVED. SHE WAS UNABLE TO PROVIDE THE DATE OF THE PATIENTS LAST DRESSING CHANGE. FOLLOWING THE PROCEDURE, THE PATIENT¿S WOUND SHOWED SIGNIFICANT SIGNS OF IMPROVEMENT AND WAS CONFIRMED TO BE HEALED AS OF (B)(6) 2025. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. ON 21-MAY-2025, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER C20377V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22152971 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06-SEP-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON HOLD ALLEGEDLY DUE TO ISSUES WITH SKIN IRRITATION, YEAST INFECTION FROM THE V.A.C.® DRAPE. THE NURSES ARE APPLYING PRESCRIPTION POWDER ON THE SKIN AND GIVING HER A WEEK BREAK DUE TO THE SKIN IRRITATION. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2023, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER C12960V009 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Fungal Infection

  MAUDE report 17834999 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10-JUL-2023 THE FOLLOWING INFORMATION WAS INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: WHEN V.A.C.® THERAPY WAS REMOVED ON (B)(6) 2023 THERE WAS IRRITATION NOTED TO THE SKIN ALLEGEDLY FROM THE V.A.C.® GRANUFOAM¿ DRESSING COMING IN TO CONTACT WITH THE PATIENT'S SKIN. SHE HAS BEEN APPLYING A POWDER TO HER SKIN TWICE A DAY AND V.A.C.® THERAPY WAS PLACED ON HOLD. ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: V.A.C.® THERAPY WAS PLACED ON HOLD ALLEGEDLY DUE TO AN INFECTION. ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE PATIENT WAS HOSPITALIZED DUE TO AN INFECTION. ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE PATIENT WAS NOT HOSPITALIZED. V.A.C.® THERAPY WAS PLACED ON HOLD ON (B)(6) 2023 BECAUSE THE PATIENT ALLEGEDLY DEVELOPED A YEAST INFECTION TO THE SKIN SURROUNDING THE WOUND. IT COULD NOT BE CONFIRMED IF THE INFECTION WAS DUE TO THE LOCATION OF THE PATIENT'S WOUND AS IT IS IN AN ABDOMINAL FOLD OR FROM THE V.A.C.® DRAPE. THE PATIENT WAS STARTED ON ORAL DIFLUCAN AND TOPICAL NYSTATIN POWDER AND AN ALTERNATIVE DRESSING WAS PUT IN PLACE. THE INFECTION HAS SINCE IMPROVED AND V.A.C.® THER

  Patient problems: Fungal Infection; Skin Inflammation/ Irritation

  MAUDE report 17476587 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE NURSE CHANGED THE V.A.C.® GRANUFOAM¿ DRESSING ON (B)(6) 2023, AND WHEN SHE CAME BACK ON (B)(6)2023, SHE COULD NOT REMOVE THE FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING. THE PATIENT WENT TO RADIOLOGY THAT DAY AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM REMAINED ON. THE DOCTOR HAD TO SURGICALLY REMOVE THE V.A.C.® GRANUFOAM¿ DRESSING AND CLOSED HIS ABDOMINAL WOUND ON (B)(6) 2023. ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE MANAGER: SHE CONFIRMED THE FOREIGN MATERIAL ALLEGED TO BE THE V.A.C.® DRESSING WAS ADHERED TO THE WOUND BED. ON (B)(6) 2023, THE SURGEON REMOVED THE V.A.C.® GRANUFOAM¿ DRESSING BY SURGICAL EXCISION. THE MANAGER WAS UNABLE TO CONFIRM IF USE ERROR WAS THE CAUSE FOR THE ADHERED V.A.C.® GRANUFOAM¿ DRESSING. SHE STATED THE CLINICAL NOTES DID NOT STATE A CAUSE. SHE WAS ALSO UNABLE TO CONFIRM WHEN THE V.A.C.® GRANUFOAM¿ DRESSING WAS PLACED IN THE WOUND. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. ON (B)(6) 2023, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17060435 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2023, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON HOLD DUE TO AN ALLEGED FUNGAL INFECTION AND SKIN IRRITATION TO PERI-WOUND, POSSIBLY FROM THE V.A.C.® DRAPE. NYSTATIN CREAM IS BEING USED AND AN ALTERNATIVE WET TO DRY DRESSING IS IN PLACE. THE WOUND IS TO BE REASSESSED AT HER FOLLOW UP APPOINTMENT WITH THE PROVIDER TO DETERMINE IF V.A.C.® THERAPY WILL BE RESUMED. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2023, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER A11028V009 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Fungal Infection; Skin Inflammation/ Irritation

  MAUDE report 16761084 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 24-MAR-2023, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER A10267V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16624831 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22-AUG-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: PATIENT REPORTED THAT V.A.C.® THERAPY WAS PLACED ON HOLD (B)(6) 2022 ALLEGEDLY DUE TO A YEAST INFECTION AND SENSITIVITY TO V.A.C.® DRAPE. ON 23-AUG-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PRACTICE MANAGER: THE PHYSICIAN ORDERED AN ORAL ANTIFUNGAL MEDICATION, DIFLUCAN, TO TREAT A PERIWOUND FUNGAL INFECTION AND SKIN IRRITATION ALLEGEDLY CAUSED BY V.A.C.® DRAPE. ON 01-SEP-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: V.A.C.® THERAPY HAS BEEN DISCONTINUED DUE TO PATIENT HAVING IRRITATION TO SKIN AND DOES NOT WANT TO USE V.A.C.® THERAPY ANYMORE. ON 08-SEP-2022, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER A01969V009 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Fungal Infection; Skin Inflammation/ Irritation

  MAUDE report 15427107 ↗
• InjurySep 12, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND NOTED A FOUL WOUND ODOR. THE PATIENT WAS AWAITING SUPPLIES AND AN EXCHANGE OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM AFTER REPORTING A TECHNICAL ISSUE WITH THE DEVICE ON (B)(6) 2022. THE PATIENT WAS UNABLE TO TROUBLESHOOT THE ISSUE ON (B)(6) 2022 AND POWERED OFF THE UNIT, LEAVING THE V.A.C.® GRANUFOAM¿ DRESSINGS IN PLACE WITHOUT ACTIVE THERAPY FOR TWO DAYS. THE PATIENT REPORTED THE NURSE PRACTITIONER HAD JUST LEFT AND ADVISED THE PATIENT THAT "EVERYTHING LOOKED OKAY EXCEPT FOR THE PATIENT'S PULSE BEING AT 123." THE PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION FOR FURTHER EVALUATION AND INDICATED THEY HAD AN APPOINTMENT SCHEDULED WITH THEIR HEALTHCARE PROVIDER IN THREE DAYS. THE PATIENT WAS AGAIN ADVISED TO SEEK MEDICAL ASSISTANCE IF THE HOME HEALTH OR HEALTHCARE PROVIDER COULD NOT SEE THE PATIENT THAT DAY AS THE WOUNDS SHOULD BE ASSESSED TO ENSURE THERE WAS NO INFECTION PRESENT. THE PATIENT STATED THAT THEY "JUST LEFT THE HOSPITAL" AND DID "NOT WANT TO GO BACK TO ER." THE PATIENT WAS PROVIDED INFORMATION REGARDING THE MANUFACTURERS' RECOM

  Patient problems: Bacterial Infection; Device Embedded In Tissue or Plaque; Fever; Pain

  MAUDE report 15401557 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S EMERGENCY CONTACT: ON (B)(6) 2022, UPON REMOVAL OF THE V.A.C.® GRANUFOAM¿ DRESSING, THE PATIENT'S WOUND ALLEGEDLY BEGAN TO BLEED, AND THE HOME HEALTH NURSE WAS REPORTEDLY UNABLE TO CONTROL THE BLEEDING. THE PATIENT SUBSEQUENTLY PRESENTED TO THE EMERGENCY ROOM AND THE PHYSICIAN ADVISED THERE WAS ALLEGEDLY A SMALL TEAR IN AN ARTERY. THE PHYSICIAN USED A SUTURE TO LIGATE THE ARTERY, RE-APPLIED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE VISITING NURSE ASSOCIATION NURSE: THE PATIENT WAS ON TWO BLOOD THINNERS, ASPIRIN AND CLOPIDOGREL, AND THE PATIENT HAS A HISTORY OF BLEEDING EVENTS PRIOR TO ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM PLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 30-MAY-2022, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9543892V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORME

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14567376 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 03-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2022, THE HOME HEALTH NURSE OBSERVED THE PATIENT WHO WAS ALLEGEDLY EXPERIENCING INCREASED PAIN AND THE NURSE EXPRESSED CONCERN FOR A POSSIBLE INFECTION. ON (B)(6) 2022, THE PHYSICIAN OBSERVED THE PATIENT AND REMOVED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE PHYSICIAN REPORTEDLY INFORMED THE PATIENT THAT THE WOUND NEEDED AIR. ON (B)(6) 2022, THE NURSE RE-APPLIED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM AND THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY. ON 28-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL EXCISION OF THE FISTULA TRACT DUE TO A PERIUMBILICAL CYST, AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS APPLIED WITH DRESSING CHANGES REPORTEDLY PERFORMED THREE TIMES A WEEK. ON (B)(6) 2022, THE PHYSICIAN OBSERVED THE PATIENT DURING THE ONE WEEK POSTOPERATIVE FOLLOW UP AND NOTED THE PATIENT'S WOUND ALLEGEDLY APPEARED INFECTED. THE PHYSICIAN ALLEGEDLY SUSPECTED THE "SPONGE" WAS NOT BEING PROPERLY PLACED DEEP ENOUGH, AS IT REPORTEDLY APPEARED SUPERFICIAL

  Patient problems: Abscess; Bacterial Infection; Pain

  MAUDE report 13976415 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 25-FEB-2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2022, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED ALLEGEDLY DUE TO SKIN IRRITATION, PAIN AND PATIENT DEVELOPED A FUNGUS AROUND THE WOUND DUE TO MOISTURE. PATIENT USING A FUNGAL POWDER AND HAD A FOLLOW UP WITH THE VASCULAR SURGEON ON (B)(6) 2022. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WILL BE ON HOLD FOR 2 WEEKS. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2022, THE NURSE STATED PATIENT HAD SOME REDNESS AND IRRITATION UNDER THE V.A.C.® DRAPE. THE PHYSICIAN DID ORDERED NYSTATIN POWDER TO TREAT THE FUNGAL INFECTION CAUSED BY MOISTURE UNDER THE V.A.C.® DRAPE. ON (B)(6) 2022, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9190886V009 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Fungal Infection

  MAUDE report 13891953 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14-FEB-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S FAMILY MEMBER: ON 13-FEB-2022, THE HOME HEALTH NURSE WAS UNABLE TO REMOVE FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING. THE PATIENT WENT TO THE EMERGENCY ROOM (ER), AND THE SURGEON REMOVED THE V.A.C.® GRANUFOAM¿ DRESSING. THE SURGEON THEN REAPPLIED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. ON 18-FEB-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE HOME HEALTH CLINICAL MANAGER: THE ER RECORD INDICATES THAT THE VASCULAR SURGEON SUCCESSFULLY REMOVED THE V.A.C.® GRANUFOAM¿ DRESSING AFTER THE ER CLINICAL TEAM ALLEGEDLY ATTEMPTED REMOVAL AND WAS UNSUCCESSFUL. THE REMOVAL METHOD BY THE SURGEON WAS NOT INDICATED. ON 04-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI VIA CLINICAL RECORDS: ON (B)(6) 2022, THE HOME HEALTH NURSE WAS UNABLE TO REMOVE THE V.A.C.® GRANUFOAM¿, DESPITE EXTENSIVE SOAKING, DUE TO THE PATIENT'S PAIN DURING THE PROCEDURE. THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT (ED) FOR FURTHER MANAGEMENT. A WOUND CARE NURSE EVALUATED THE PATIENT AND WAS ALSO UNABLE TO REMOVE THE V.A.C.® GRANUFOAM¿. THE VASCULAR SURGEON WAS CALLED TO EVALUATE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13790117 ↗
• InjuryJan 25, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 19-NOV-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2021, THE PATIENT ALLEGEDLY DEVELOPED A BAD RASH AND V.A.C.® THERAPY WAS PLACED ON HOLD. THE PATIENT HAS A FOLLOW-UP APPOINTMENT SCHEDULED ON (B)(6) 2021, AND THE PHYSICIAN WILL REASSESS THE WOUND. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CENTER OFFICE MANAGER: THE REPORTED RASH WAS A FUNGAL INFECTION LOCALIZED UNDER THE V.A.C.® DRAPE DUE TO THE PATIENT LEAVING THE V.A.C.® DRAPE ATTACHED OVER NIGHT WITHOUT ACTIVE V.A.C.® THERAPY. THE FUNGAL INFECTION WAS TREATED WITH ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9300889V009 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Fungal Infection

  MAUDE report 13348718 ↗
• InjuryJan 7, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: ON (B)(6) 2021, THE PATIENT WAS ALLEGEDLY ADMITTED TO THE HOSPITAL DUE TO A WOUND INFECTION. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CENTER MEDICAL ASSISTANT: THE PHYSICIAN STATED THAT THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS NOT APPLIED PROPERLY BY THE HOME HEALTH NURSE AND IT CAUSED THE WOUND TO BECOME INFECTED. NO ADDITIONAL INFORMATION AVAILABLE. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CENTER MEDICAL ASSISTANT: THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT APPLIED PROPERLY BY THE HOME HEALTH NURSING TEAM. NO ADDITIONAL INFORMATION AVAILABLE. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9108886V009 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 13192658 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 21-JUL-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2021 THE PATIENT IS OFF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM ALLEGEDLY DUE TO A YEAST INFECTION WITH REDNESS AND BURNING TO THE PERIWOUND WHERE THE V.A.C.® DRAPE WAS PLACED. THE PHYSICIAN HAS TRIED DIFFERENT TREATMENTS, INCLUDING NYSTATIN AND DIFLUCAN, THAT WERE NOT EFFECTIVE. THE PHYSICIAN DECIDED TO PLACE AN ALTERNATE DRESSING SINCE THE PATIENT'S WOUND HAS BEEN PROGRESSING WELL. ON 10-AUG-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE HEALTHCARE PROVIDER VIA THE MEDICAL QUESTIONNAIRE: THE PATIENT ALLEGEDLY EXPERIENCED A YEAST INFECTION DUE TO MOISTURE ACCUMULATION, AND THE PHYSICIAN REPORTEDLY TRIED DIFFERENT TREATMENTS, INCLUDING ANTIFUNGAL POWDER, THAT WERE INEFFECTIVE. NO ADDITIONAL INFORMATION WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9054887V009 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS DISCARDED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Fungal Infection

  MAUDE report 12339884 ↗
• InjuryAug 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON 16-JUN-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT STATED THAT THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED ON (B)(6) 2021 AT THE WOUND CARE CENTER DUE TO IRRITATION. THE PATIENT STATED THAT THE DOCTOR WANTED THE V.A.C.® TO REMAIN OFF FOR A DAY. THE V.A.C.® WAS REAPPLIED ON (B)(6) 2021. ON 08-JUL-2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI VIA THE MEDICAL INVESTIGATION QUESTIONNAIRE: ON (B)(6) 2021, WHEN THE DRESSING WAS REMOVED, VISUAL ASSESSMENT OF WOUND REVEALED THAT YEAST WAS PRESENT AROUND THE WOUND FROM ALLEGED LEAKING V.A.C.® GRANUFOAM¿ DRESSING AND PHYSICIAN LEFT V.A.C.® OFF TO HELP CLEAR THE YEAST. ON 08-JUL-2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF THE PHYSICIAN'S ORDERS DATED (B)(6) 2021: USE LOTRISONE TO PERIWOUND YEAST TWO TIMES PER WEEK FOR ONE WEEK. HOME HEALTH IS TO REAPPLY V.A.C.® ON (B)(6) 2021. ON 08-JUL-2021, THE FOLLOWING INFORMATION WAS RECEIVED BY KCI AFTER A REVIEW OF THE WOUND CARE CENTER PROGRESS NOTE DATED (B)(6) 2021: THE ULCER IS IMPROVED, HOWEVER, THERE IS A GOOD BIT OF EXCORIATION AND PROBABLE FOUND FUNGI AROUND THE AREA. PERIWOUND ASSESSMENT: ERYT

  Patient problems: Fungal Infection

  MAUDE report 12285097 ↗
• InjuryJul 28, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 09-AUG-2021, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9054887V009 WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12239093 ↗
• InjuryJun 18, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 19-MAY-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE HOME HEALTH NURSE CHANGED THE V.A.C.® GRANUFOAM¿ DRESSING AFTER FOUR DAYS DUE TO A MISCOMMUNICATION BETWEEN THE HOME HEALTH AGENCY AND WOUND CARE CLINIC. ALLEGEDLY AN "ARTERY WAS SNAPPED" CAUSING INCREASED BLEEDING, AND THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR EMERGENCY SURGERY. ON (B)(6) 2021, THE REPLACEMENT ACTIV.A.C.¿ THERAPY SYSTEM WAS SCHEDULED TO BE APPLIED. ON 20-MAY-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE CLINICAL MANAGER: THE HOME HEALTH NURSE REMOVED THE V.A.C.® GRANUFOAM¿ DRESSING AND WAS UNABLE TO STOP THE BLEEDING. PRESSURE WAS APPLIED UNTIL THE AMBULANCE ARRIVED. SHE STATED THERE WAS NO "SNAPPING OF ARTERY" AND CONFIRMED THERE WAS MISCOMMUNICATION WITH THE HOSPITAL SCHEDULING THE PATIENT'S FOLLOW-UP APPOINTMENT WITH THE WOUND CARE CLINIC, AND THE PATIENT WAS UNAWARE OF ORDERS TO FOLLOW-UP WITH WOUND CARE CLINIC PRIOR TO START OF HOME HEALTH. ON 20-MAY-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE REGISTERED NURSE: THE PATIENT REQUIRED PLACEMENT OF A SURGICAL SUTURE TO CEASE THE BLEEDING THAT ALLEGEDLY OCCURRED FROM THE REMOVAL OF THE V.A.C.® G

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12024837 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2021, V.A.C.® THERAPY WAS REMOVED ALLEGEDLY DUE TO A BLOOD VESSEL THAT WAS BLEEDING AND REQUIRED A STITCH. ON (B)(6) 2021, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REAPPLIED. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE PRACTITIONER: THE PATIENT REQUIRED PLACEMENT OF A SINGLE SUTURE TO CEASE THE BLEEDING THAT ALLEGEDLY OCCURRED FROM THE REMOVAL OF THE V.A.C.® GRANUFOAM¿ DRESSING FROM THE WOUND BED. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN'S MEDICAL OFFICE SPECIALIST: ON (B)(6) 2021, THE PHYSICIAN NOTED SIGNIFICANT BLEEDING AND A STITCH WAS APPLIED. ON (B)(6) 2021, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS RE-APPLIED. THE MEDICAL OFFICE SPECIALIST CONFIRMED THE PATIENT WAS NOT ON ANY BLOOD THINNERS. REVIEW OF RECORDS NOTED THE FOLLOWING: ON (B)(6) 2021, THE PHYSICIAN OBSERVED THE PATIENT AND NOTED LEFT GROIN SURGICAL WOUND MEASURES 5.25CM X 1.9CM X 1.8CM; 100% GRANULATED TISSUE BED, SIGNIFICANT BLEEDING FROM A SQ [SUBCUTANEOUS] VESSEL. TREATMENT NOTED: THE PATIENT'S WOUND IS PROG

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11975739 ↗
• InjuryJun 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2021, THE PATIENT REPORTED DIFFICULTY IN MAINTAINING A SEAL WITH THE V.A.C.® DRAPE DUE TO THE SHALLOW DEPTH OF THE WOUND. THE NURSE REPORTED THAT THE SEAL ISSUE RESOLVED WITH CUTTING THE V.A.C.® GRANUFOAM¿ DRESSING IN HALF. THE NURSE OBTAINED A WOUND CULTURE AT THAT TIME ALLEGEDLY DUE TO BLOOD NOTED IN THE DRAINAGE. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON HOLD ALLEGEDLY DUE TO A WOUND INFECTION AND THE PATIENT WAS STARTED ON ANTIBIOTICS. THE WOUND WOULD BE REASSESSED THE FOLLOWING WEEK AND A DETERMINATION TO RESUME OR DISCONTINUE V.A.C.® THERAPY WOULD BE MADE AT THAT TIME. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN'S NURSE: ON (B)(6) 2021, WOUND CULTURE RESULTS OBTAINED (B)(6) 2021 CONFIRMED A WOUND INFECTION AND, TO DATE, V.A.C.® THERAPY HAS NOT RESUMED. THE PATIENT HAS A COLOSTOMY BAG DUE TO A PRE-EXISTING COLOENTERIC FISTULA, FOR WHICH MAINTAINING A SEAL WITH THE COLOSTOMY BAG HAS LED TO A DETERIORATION IN THE WOUND FROM BOWEL LEAKAGE. DUE TO T

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection

  MAUDE report 11940037 ↗
• InjuryMay 19, 2021Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  ON (B)(6) 2021, A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI QUALITY ENGINEERING AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11852668 ↗
• InjuryJan 29, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 30-DEC-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, THE PATIENT WAS PLACED ON AN ALTERNATE DRESSING ALLEGEDLY DUE TO A FOUL ODOR AND A FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING ADHERING TO THE WOUND. THE PATIENT BELIEVES THE WOUND IS INFECTED. ON 26-JAN-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE HOME HEALTH NURSE: THE PATIENT WAS LAST SEEN ON (B)(6) 2020 BY THE HOME HEALTH AND MISSED A FOLLOW UP APPOINTMENT ON (B)(6) 2020. THE NURSE REPORTED THE PATIENT IS NON-COMPLIANT. ON 27-JAN-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE HOME HEALTH NURSE CASE MANAGER: THE PATIENT WAS LAST SEEN ON (B)(6) 2020 AND THE NURSE NOTED THAT THE PATIENT HAD SELF-REMOVED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. A SMALL FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS ADHERED TO THE WOUND AND THE NURSE WAS UNABLE TO COMPLETELY REMOVE. THERE WAS NO ODOR OR ANY SIGNS OR SYMPTOMS OF INFECTION NOTED. THE PHYSICIAN WAS NOTIFIED AND THE PATIENT WAS PLACED ON AN ALTERNATE DRESSING AND INSTRUCTED TO FOLLOW-UP WITH PHYSICIAN. THE NURSE REPORTED THE PATIENT IS NON-COMPLIANT AND MISSED MULTI

  Patient problems: Bacterial Infection; Foreign Body In Patient

  MAUDE report 11252795 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2020, A FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS REMOVED FROM THE WOUND, THE WOUND WAS INFLAMED AND BEGAN TO BLEED AND THE PATIENT WENT TO THE EMERGENCY ROOM TO RESOLVE. PER THE PATIENT, THE NURSE STATED A PROTECTIVE BARRIER WAS NOT USED BETWEEN THE FOAM AND THE WOUND BED AND POTENTIALLY CAUSED THE FOREIGN MATERIAL TO ADHERE. ON (B)(6) 2020, THE PATIENT UNDERWENT A DEBRIDEMENT TO REMOVE THE REMAINING FOREIGN MATERIAL FROM THE WOUND. ON (B)(6) 2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE BLEEDING EXPERIENCED BY THE PATIENT WAS RESOLVED WITH PRESSURE, AND AN ALTERNATE DRESSING WAS APPLIED. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING IS CURRENTLY PENDING COMPLETION.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10766848 ↗
• InjurySep 16, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 17-AUG-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: A FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS ADHERED TO THE PATIENT'S WOUND AND WAS SURGICALLY REMOVED WITHOUT LOCAL ANESTHETIC. WHEN THE FOREIGN MATERIAL WAS REMOVED THE PATIENT EXPERIENCED EXCRUCIATING PAIN AND THE WOUND BECAME IRRITATED. FOR THE PAST THREE WEEKS, THE HOME HEALTH ALLEGEDLY PERFORMED DRESSING CHANGES WITHOUT REMOVING THE V.A.C.® GRANUFOAM¿ DRESSING. ON 22-AUG-2020, CLINICAL PROGRESS NOTES WERE PROVIDED TO KCI BY THE PHYSICIAN: IT WAS NOTED "PATIENT SEEN TWO WEEKS POST-OP. HOME NURSING NEVER REMOVED THE SPONGE SECONDARY TO PATIENT DISCOMFORT. PATIENT'S MEDICAL TEAM WAS NOT INFORMED." THE PHYSICIAN NOTED THE FOAM WAS REMOVED IN ITS ENTIRETY IN THE CLINIC AND A NEW WOUND OR INCISION WAS NOT REQUIRED TO REMOVE THE FOREIGN MATERIAL. ON 11-SEP-2020, CLINICAL PROGRESS NOTES WERE PROVIDED TO KCI BY THE PHYSICIAN'S OFFICE: ON 12-AUG-2020, IT WAS NOTED THE PATIENT REPORTED THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT REMOVED AND THE PHYSICIAN REMOVED IT IN THE CLINIC. AN ALTERNATE DRESSING WAS APPLIED. THE WOUND BED WAS NOTED AS HEALTHY AND GRANULATING WELL WITH NO PRESENT INDICATIO

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 10544528 ↗