Entre PD08-URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816305020007), received between Sep 13, 2019 and May 19, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS SHIPPED AN ENTRE CONTROLLER PD08-U (B)(4) AND TWO ENTRE SHORT FULL LEG GARMENTS L-FL-SH-A, LOT 018014, AND AN ENTRE Y-CONNECTOR PD08-U, LOT 300575 ON (B)(6) 2021. THE PATIENT STARTED USING THE ENTRE SYSTEM THE END OF (B)(6) 2021. THEY USED THE ENTRE SYSTEM ABOUT 2 TO 2.5 WEEKS WITH NO ISSUES, THEY ENJOYED THE "MASSAGE" AND REPORTED THEY CHANGED THE PRESSURE TO MEDIUM FROM LOW A FEW TIMES. ON (B)(6) 2022, THE PATIENT NOTED LEFT KNEE PAIN BUT CONTINUED THE USE THE ENTRE SYSTEM AND REPORTED NO OTHER ISSUES, SO THEY USED THE ENTRE SYSTEM THE FOLLOWING DAY AND HAD PAIN, SO THEY STOPPED USING THE ENTRE SYSTEM ON THE LEFT LEG ONLY. ON (B)(6) 2022, THE PATIENT CALLED TACTILE MEDICAL AND STATED THEY WERE SEEN BY THEIR NEUROLOGIST AND DIAGNOSED WITH NERVE DAMAGE AND CHRONIC COMPARTMENT SYNDROME, THE PATIENT STATED IT WILL TAKE OVER A YEAR TO RECOVER AND WILL CONTINUE WITH CURRENT TREATMENT- ELEVATION, ICE, PREDNISONE, AND PAIN MEDICATION. NEUROLOGIST ALSO TOLD THE PATIENT THEY POSSIBLY COULD HAVE HAD A WEAK VESSEL WHICH LED TO THE BLEEDING (HEMATOMA), AND THE BLOOD GOT HARD AND ENCAPSULATED IN THE COMPARTMENT AND AROUND THE NERVE CAUSING THE PAIN. TACTILE MEDICAL REVIEWED THI

  Patient problems: Nerve Damage

  MAUDE report 14438307 ↗
• InjurySep 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ENTRE CONTROLLER PD08-U AND SHORT FULL LEG GARMENT L-FL-SH-A WERE ORDERED ON 11/12/2018, SHIPPED ON 11/15/18 AND DELIVERED ON 11/15/2018. PATIENT DELAYED USING THE ENTRE SYSTEM, CONTROLLER AND GARMENT, UNTIL HER FAMILY WAS IN TOWN TO ASSIST HER, SHE THEN USED IT A TOTAL OF THREE TIMES DURING THE WEEK OF (B)(6) 2019. SHE STATED THE DEVICE WAS INITIALLY SET ON LOW PRESSURE AND THEN FELT THERE WASN'T ENOUGH PRESSURE SO SHE CHANGED THE PRESSURE TO MEDIUM, SHE STATED THEY NEVER USED IT ON HIGH. AFTER THE THIRD USE THE PATIENT NOTICED PAIN AND SIGNIFICANT INCREASE IN SWELLING IN BOTH LEGS. PRIOR TO USING THE ENTRE SYSTEM THE PATIENT STATED THEIR LEFT LEG HAD SWELLING FOR A LONG TIME, BUT RIGHT LEG WAS OK. SHE NOW STATE THE RIGHT AND LEFT LEG ARE BOTH SIGNIFICANTLY SWOLLEN AND PAINFUL. SHE HAS NOT USED THE ENTRE SYSTEM SINCE THE ONSET OF THESE SYMPTOMS. PATIENT CALLED THE DOCTOR'S OFFICE THE WEEK OF (B)(6) 2019 TO REPORT SYMPTOMS AND WAS SEEN BY THE PRESCRIBER ON (B)(6) 2019. IMAGING REVEALED DVTS BILATERALLY IN MID TO DISTAL REGION OF SUPERFICIAL FEMORAL VEINS, ABOVE THE KNEES. PT BEGAN ANTICOAGULATION THERAPY AFTER (B)(6) 2019. PATIENT HAS BEEN ADVISED TO AVOID THE PNEUMATIC COMPRESSION

  Patient problems: Thrombosis

  MAUDE report 9035483 ↗