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TENA
Essity Hygiene and Health AB · Model SmartCare Transmitter · UDI-DI 00768702912808
10
510(k) clearances
965
Adverse events (1 deaths)
4
Recalls
19
Facilities
Description
The TENA SmartCare Change Indicator consists of the TENA SmartCare Transmitter and the TENA SmartCare Sensor Strip. It is an assortment of wetness indicators to be used as an accessory to an absorbent hygiene product used by dependent individuals suffering from incontinence problems.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-30 | Baxter Healthcare Corporation | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d |
| 2022-09-30 | Baxter Healthcare Corporation | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d |
| 2022-09-30 | Baxter Healthcare Corporation | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d |
| 2022-09-30 | Baxter Healthcare Corporation | Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/d |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.