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Chummie
Theos Medical Systems, Inc. · Model TCE25O · UDI-DI 00854950002191
10
510(k) clearances
965
Adverse events (1 deaths)
4
Recalls
19
Facilities
Description
A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.
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.