V.A.C. GRANUFOAMRecalls & reported problems across all models

We found 3 models of V.A.C. GRANUFOAM by Kci USA, Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2017 and Oct 16, 2025 — classified as 35 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported V.A.C. GRANUFOAM problems

V.A.C. GRANUFOAM models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• V.A.C.® GRANUFOAM™ M8275052/5 M8275052/10

  Negative Pressure Wound Therapy Powered Suction Pump
  27 reports
• V.A.C.® GRANUFOAM™ M8275051/5 M8275051/10

  Negative Pressure Wound Therapy Powered Suction Pump
  4 reports
• V.A.C.® GRANUFOAM™ M8275053/5 M8275053/10

  Negative Pressure Wound Therapy Powered Suction Pump
  4 reports

Recent V.A.C. GRANUFOAM adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMay 14, 2025Material Fragmentation; Material Fragmentation

  ON 24-APR-2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: A PATIENT ALLEGEDLY HAD SMALL BITS OF BLACK FOAM EMBEDDED IN THE WOUND. THIS MAKES A TOTAL OF THREE PATIENTS NOW; SOME WITH AS MANY AS 75 PIECES OF BLACK FOAM. THERE WAS SOME MATERIAL PRESENT COMING FROM THE SMALL V.A.C.® GRANUFOAM¿ DRESSING OUT OF THE PACKAGE. ON 29-APR-2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: THE MOST RECENT PATIENT HAD V.A.C.® GRANUFOAM¿ DRESSING PLACED, LOT NUMBER C12078V011. THE PREVIOUS TWO PATIENTS WERE TRANSFERRED FROM ANOTHER ACUTE CARE FACILITY WITH EMBEDDED V.A.C.® GRANUFOAM¿ DRESSING SO THERE ARE NO LOT NUMBERS AVAILABLE. ALL THREE PATIENTS REQUIRED SHARP AND MECHANICAL DEBRIDEMENT TO REMOVE THE EMBEDDED FOAM. THE EXACT DATES OF OCCURRENCE OF THE TWO PREVIOUS PATIENTS WERE UNKNOWN. ON 30-APR-2025, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER C12078V011. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE ALLEGED PATIENT WITH EMBEDDED SMALL V.A.C.® GRANUFOAM¿ DRESSING FOR LOT NUMBER C12078V011 IS REPORTED UNDER MDR-3009897021-2025-00018. THE ALLEGED PREVIOUS TWO PATIENTS WITH EMBEDDED V.A.C.® GRANUFOAM¿ DR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22022622 ↗
• 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 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE PATIENT HAS A DOCTOR'S APPOINTMENT TOMORROW DUE TO THE HOME HEALTH NURSE REPORTING AN ALLEGED ODOR FROM THE WOUND ON (B)(6) 2022. ON 08-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM REMAINS IN USE, HOWEVER, THE PHYSICIAN PRESCRIBED DOXYCYCLINE AND FLUCONAZOLE TO TREAT SKIN IRRITATION AND A YEAST INFECTION ALLEGEDLY FROM THE V.A.C.® DRAPE. ON 28-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN ASSISTANT: ON 03-JUN-2022, THE PHYSICIAN ORDERED AN ORAL ANTIFUNGAL MEDICATION TO TREAT A PERIWOUND FUNGAL INFECTION AND DUE TO CONCERN FOR PERIWOUND CELLULITIS, AN ORAL ANTIBIOTIC WAS ALSO PRESCRIBED. A WOUND CULTURE WAS NOT OBTAINED. ON 21-JUN-2022, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 60331235V010 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: Cellulitis; Fungal Infection

  MAUDE report 14936911 ↗
• 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 ↗
• InjuryMay 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE HOME HEALTH AGENCY NURSE HAS NOT SHOWN UP SINCE THE VETERAN AFFAIRS NURSE APPLIED V.A.C.® THERAPY ON (B)(6) 2022. THE PATIENT'S FAMILY MEMBER IS A NURSE AND PERFORMED THE DRESSING CHANGE DUE TO TECHNICAL ISSUES ON (B)(6) 2022. THE FAMILY MEMBER NOTICED V.A.C.® GRANUFOAM¿ DRESSING WAS PLACED ON INTACT SKIN AND ALLEGEDLY A NEW SORE WAS PRESENT WITH SOME REDNESS. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE CASE MANAGER: THE PATIENT WAS NOTED TO HAVE ALLEGEDLY DEVELOPED NECROTIC TISSUE AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS DISCONTINUED. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS WORKING JUST FINE AND GRANULATING WELL. WHEN THE PATIENT WAS SEEN LAST WEEK, THE V.A.C.® GRANUFOAM¿ DRESSING WAS PUT ON TOP OF THE LIP OF SKIN AND WHEN V.A.C.® THERAPY WAS TURNED ON AND COMPRESSED CONTINUOUSLY, THERE WAS A LITTLE BIT OF EDGE NECROSIS. THE V.A.C.® GRANUFOAM¿ DRESSING WASN'T CONFINED IN THE WOUND AND WAS OVERSIZED. THE PATIENT'S WOUND

  Patient problems: Necrosis; Skin Inflammation/ Irritation

  MAUDE report 14489521 ↗
• 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 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2022, AFTER REMOVAL OF THE V.A.C.® GRANUFOAM¿DRESSING BY A FAMILY MEMBER, THE PATIENT ALLEGEDLY STARTED BLEEDING AND PRESENTED TO THE HOSPITAL FOR MEDICAL ATTENTION. THE PATIENT REPORTED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS RESUMED. ON 10-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY (B)(6): ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF BLEEDING FROM HIS SURGICAL SITE. THE PHYSICIAN NOTED MINOR BLEEDING TO A SMALL SUBCUTANEOUS VESSEL AND USED A SUTURE TO LIGATE. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS RESUMED. ON (B)(6) 2022, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9353894V011 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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13971396 ↗

Other Kci USA, Inc. products

• PREVENA RESTOR BELLA•FORM3 models · 1 reports · 1 recall
• PREVENA PLUS2 models · 1 reports · 1 recall
• PREVENA RESTOR ARTHRO•FORM2 models · 0 reports · 1 recall
• V.A.C.ULTA2 models · 0 reports · 1 recall