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TraumaGuard Intra-abdominal Pressure-Sensing System

SENTINEL MEDICAL TECHNOLOGIES · Model TraumaGuard Kohden Cable · UDI-DI 00860003478752

PHUEZLEXY Prescription
2
510(k) clearances
114
Adverse events (5 deaths)
1
Recalls
12
Facilities

Description

The Reusable Temperature Cable connects to a temperature-sensing TraumaGuard catheter's thermistor plug and temperature port on the Monitor for continuous temperature measurement.

Recalls

DateFirmReason
2020-01-13C.R. Bard IncLeaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be co

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Data 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.