LOCATOR R-Tx 31802-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840481122651), received between May 7, 2022 and May 7, 2022 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BABY HAD A SUBCUTANEOUS FAT NECROSIS ON THE BACK SHOULDER AREA. TERRITORY MANAGER CHECKED WITH THE TEAM ON BOTH DAY AND NIGHT SHIFT DURING THE 4 DAYS WHEN THE PRODUCT WAS USED. AND STATED THAT THE WATER TEMPERATURE WAS WARM FOR THE ENTIRE 3 DAYS AND BABY WAS CALM. MANAGER WAS NOT SURE OF PATIENT RELATED ISSUES THAT MIGHT HAVE PREDISPOSED THE BABY TO HAVE THIS OR IF THE NURSE TEAM DID NOT TURN ENOUGH. AND WAS NOT CONVINCED THAT THIS WAS CAUSED BY THE PRODUCT. SINCE IT WAS JUST A WATER BLANKET, IT LIKELY WOULD HAVE BEEN FAR WORSE, AS IT WOULD HAVE LIKELY HAPPENED REGARDLESS. PER FOLLOW UP EMAIL RESPONSE RECEIVED ON 18APRIL2022, IT WAS STATED THAT THE THERAPY WAS COMPLETED ON THE PATIENT. THE SUBCUTANEOUS FAT NECROSIS WAS NOTED TO BILATERAL (B/L) POSTERIOR SCAPULAR AREAS AND DESCENDING TO BILATERAL (B/L) FLANK REGIONS. THIS WAS NOTICED AFTER THE THERAPY WAS STOPPED AND IT WAS CONTRIBUTED TO THE PAD USE AND WAS PENDING A DERMATOLOGY CONSULTATION. MEDICATIONS THAT WERE GIVEN TO THE PATIENT WERE ¿TPN/SMOF LIPIDS, DILUTE MORPHINE 0.18MG, AND TYLENOL¿. THE PAD LOT NUMBER WAS NGFT3412, AND NO SAMPLE IS AVAILABLE AS THE PADS WERE THROWN AWAY.

  Patient problems: Necrosis

  MAUDE report 14316807 ↗