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Reports of Injuries, Deaths

Over the past two years, FDA has received six death and 77 injury reports associated with NPWT devices. Most deaths occurred at home or in long-term care facilities. Bleeding was the most serious complication, occurring in all six deaths and in 17 of the injuries.

According to these reports, extensive bleeding has occurred in patients
with blood vessel grafts in the leg
with breastbone or groin wounds
receiving medication for blood clots
during removal of dressings attached to the tissues

The reports also included cases of infections from original open infected wounds worsening due to pieces of dressing that remained in the wound, and of injury from foam dressing pieces and foam sticking to tissues or clinging to wounds. Most of these patients required surgery, additional hospitalization, and antibiotics.

FDA is addressing these problems and will continue monitoring adverse events associated with NPWT devices.

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