SNAP™ SKTF15X15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849554005464), received between Aug 25, 2017 and Apr 20, 2018 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON MAR 22 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI THE PHYSICIAN: THE SNAP¿ THERAPY SYSTEM WAS IN USE ON THE PATIENT¿S SACRO-COCCYGEAL CYST. THE PATIENT EXPERIENCED HEAVY BLEEDING UPON REMOVING THE DEVICE DURING A DRESSING CHANGE. THE FOLLOWING ACTIONS WERE TAKEN WITHIN THE HEALTHCARE INSTITUTION FOR PATIENT TREATMENT: INTERVENTION BY THE FIRE BRIGADE, EVACUATION TO EMERGENCY ROOM, PATIENT¿S WOUND WAS CAUTERIZED, AND A COMPRESSION DRESSING WAS APPLIED. ON MAR 31 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHARMACIST: THE PATIENT¿S OUTCOME ATTRIBUTED TO EVENT WAS NOTED AS HOSPITALIZATION ¿ INITIAL OR PROLONGED. THE CLINICIANS REPORTEDLY EXPERIENCED ¿SOME¿ DIFFICULTY MAINTAINING HEMOSTASIS DURING THE 10 DAYS PRIOR TO THE APPLICATION OF THE SNAP¿ THERAPY SYSTEM ON (B)(6) 2018. ON (B)(6) 2018, UPON DRESSING REMOVAL, THE WOUND ALLEGEDLY BECAME HEMORRHAGIC AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THE PATIENT HAS BEEN DISCHARGED HOME. THE HEALTHCARE PRACTITIONER STATED THE SNAP¿ THERAPY SYSTEM MAY HAVE CAUSED THE ADVERSE EVENT WITH THE INTERVENTION NOTED AS PRECAUTIONARY MEASURES. ON APR 03 2018, MEDICAL DEVICE VIGILANCE INCIDENT DECLARATION (B)(4) WAS REC

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7448245 ↗
• InjuryAug 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON JUL 26 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: AN IN-SERVICE FOR THE SNAP¿ THERAPY SYSTEM WAS PROVIDED ON JUL 26 2017 TO THE WOUND CLINIC STAFF. AS PART OF THE TRAINING THE NURSES THAT ATTENDED THE IN-SERVICE APPLIED THE SNAP¿ THERAPY SYSTEM TO EACH OTHER. THE NURSE MANAGER FOR THE CLINIC ALLEGED THAT WITH THE APPLICATION OF THE SNAP¿ DRESSING KIT A NURSE DEVELOPED A RASH WITH SWELLING TO THE EYES AND THE NURSE WENT TO SEEK FURTHER MEDICAL ATTENTION. ON JUL 27 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CLINIC NURSE MANAGER: THE NURSE HAD AN ALLERGIC REACTION TO THE SNAP¿ DRESSING KIT DURING THE IN-SERVICE THAT HAD THE APPEARANCE OF A RED RASH THAT EXTENDED BEYOND THE TREATMENT AREA LOCATED ON THE NURSE'S ARM. THE NURSE ALSO HAD SWELLING TO BOTH EYES AND THE NURSE WENT TO THE EMERGENCY ROOM AND RECEIVED MEDICAL INTERVENTION TO RESOLVE THE RASH AND EYE SWELLING. SHE DID NOT KNOW EXACTLY WHAT MEDICAL INTERVENTION WAS DONE TO RESOLVE THE RASH AND SWELLING AS THE MEDICAL REPORT HAS NOT BEEN PROVIDED TO HER. NO FURTHER MEDICAL INFORMATION WAS PROVIDED. ON AUG 24 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE

  Patient problems: Reaction

  MAUDE report 6821406 ↗
• InjuryAug 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: AN IN-SERVICE FOR THE SNAP¿ THERAPY SYSTEM WAS PROVIDED ON (B)(6) 2017 TO THE WOUND CLINIC STAFF. AS PART OF THE TRAINING THE NURSES THAT ATTENDED THE IN-SERVICE APPLIED THE SNAP¿ THERAPY SYSTEM TO EACH OTHER. THE NURSE MANAGER FOR THE CLINIC ALLEGED THAT WITH THE APPLICATION OF THE SNAP¿ DRESSING KIT A NURSE DEVELOPED A REACTION OF ITCHING THAT EXTENDED BEYOND THE TREATMENT AREA AND THE NURSE WENT TO SEEK FURTHER MEDICAL ATTENTION. ON JUL 27 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CLINIC NURSE MANAGER: THE NURSE HAD AN ALLERGIC REACTION TO THE SNAP¿ DRESSING KIT DURING THE IN-SERVICE THAT HAD RESULTED IN THE NURSE HAVING A "SEVERE ITCHING OF THE SKIN" THAT EXTENDED BEYOND THE TREATMENT AREA LOCATED ON THE NURSE'S ARM. THE NURSE WENT TO THE EMERGENCY ROOM AND RECEIVED MEDICAL INTERVENTION TO RESOLVE THE REACTION. SHE DID NOT KNOW EXACTLY WHAT MEDICAL INTERVENTION WAS DONE TO RESOLVE THE ITCHING REACTION AS THE MEDICAL REPORT HAS NOT BEEN PROVIDED TO HER. NO FURTHER MEDICAL INFORMATION WAS PROVIDED. ON AUG 24 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY TH

  Patient problems: Reaction

  MAUDE report 6821386 ↗
• InjuryAug 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON JUL 26 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: AN IN-SERVICE FOR THE SNAP¿ THERAPY SYSTEM WAS PROVIDED ON (B)(6) 2017 TO THE WOUND CLINIC STAFF. AS PART OF THE TRAINING, THE NURSES THAT ATTENDED THE IN-SERVICE APPLIED THE SNAP¿ THERAPY SYSTEM TO EACH OTHER. THE NURSE MANAGER FOR THE CLINIC ALLEGED THAT WITH THE APPLICATION OF THE SNAP¿ DRESSING KIT A NURSE DEVELOPED A PINPOINT RAISED RASH THAT EXTENDED BEYOND THE TREATMENT AREA AND THE NURSE WENT TO SEEK FURTHER MEDICAL ATTENTION. ON (B)(6) 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE WOUND CARE CLINIC NURSE MANAGER: THE NURSE HAD AN ALLERGIC REACTION TO THE SNAP¿ DRESSING KIT DURING THE IN-SERVICE THAT HAD THE APPEARANCE OF A PINPOINT RAISED RASH THAT EXTENDED BEYOND THE TREATMENT AREA LOCATED ON THE NURSE'S ARM. THE NURSE WENT TO THE EMERGENCY ROOM AND RECEIVED MEDICAL INTERVENTION TO RESOLVE THE RASH. SHE DID NOT KNOW EXACTLY WHAT MEDICAL INTERVENTION WAS DONE TO RESOLVE THE RASH AS THE MEDICAL REPORT HAS NOT BEEN PROVIDED TO HER. NO FURTHER MEDICAL INFORMATION WAS PROVIDED. ON (B)(6) 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: THE NURSE W

  Patient problems: Reaction

  MAUDE report 6821367 ↗