PWD™ Platform Wound Dressing Negative Pressure System
APPLIED TISSUE TECHNOLOGIES LLC · Model 1 · UDI-DI 00850590008265
Description
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | KCI USA, INC. | Due to increase in complaints related to leak alarms |
| 2024-11-05 | KCI USA, INC. | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
| 2024-10-02 | Smith & Nephew Medical, Ltd. | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2020-06-08 | KCI USA, INC. | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2019-12-02 | Medela Inc | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
| 2018-02-07 | Medela Inc | Device may display a battery missing error. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs