V.A.C. DERMATAC™Recalls & reported problems
Kci USA, Inc. · V.A.C. DERMATAC™ DRAPE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554005242), received between May 17, 2024 and May 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Impaired Healing1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak
ON 22-APR-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: SHE ALLEGEDLY DEVELOPED SOME IRRITATION AROUND THE WOUND. HER HOME HEALTH NURSE USED THE DERMATAC¿ DRAPE THAT WAS ORDERED BY THE WOUND CARE CENTER, WHICH MADE HER SKIN WORSE. SHE STATED THAT SHE WOULD BE FOLLOWING UP WITH HER DOCTOR TOMORROW TO ASSESS THE WOUND. SHE ADDED THAT SHE WOULD POSSIBLY BE ADMITTED TO THE HOSPITAL BECAUSE THE WOUND HAD WORSENED. ON 29-APR-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE DOCTOR OF OSTEOPATHIC MEDICINE: THE PATIENT'S SKIN IRRITATION WAS ASSESSED TO BE MODERATE TO SEVERE, WHICH WAS CONFIRMED TO CAUSE THE WOUND TO DETERIORATE. THE PROVIDER CONFIRMED THE ALLEGED EVENT TO BE A COMBINATION OF THE DERMATAC¿ DRAPE NOT SEALING PROPERLY, AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM NOT FUNCTIONING PROPERLY. THE PATIENT REQUIRED SURGICAL DEBRIDEMENT AT THE WOUND CARE CENTER. WOUND CARE TREATMENT WAS CHANGED, V.A.C.® THERAPY WAS DISCONTINUED, AND THE PATIENT IS IMPROVING. ADDITIONAL INFORMATION FROM THE PROVIDER WAS REQUESTED VIA FAX REGARDING THE INFORMATION RECEIVED. ON 06-MAY-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE DOCTOR OF OSTEOPATHIC MEDICI
Patient problems: Impaired Healing; Skin Inflammation/ Irritation
MAUDE report 19343325 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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