MEDRAD® Disposable Prostate Coil BPX 15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00616258009193), received between Jul 26, 2018 and Jul 26, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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.

• InjuryJul 26, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE SITE REPORTED THE FOLLOWING: A (B)(6) MALE PATIENT WITH ELEVATED PSA LEVELS WAS UNDERGOING AN MRI OF THE PROSTATE. DURING PRE-SCREENING THE PATIENT DENIED ANY HISTORY OF RECTAL PROBLEMS OR TRAUMA. THE PATIENT WAS PLACED UNDER SEDATION BY ANESTHESIA STAFF AND A BPX 15 ENDORECTAL COIL WAS INSERTED BY A PROSTATE CLINIC NURSE INTO THE PATIENT'S RECTUM WITHOUT ANY DIFFICULTY NOTED. THE SITE REPORTED THAT THE INSERTION WAS DONE FOLLOWING THE INSTRUCTIONS FOR USE AND THAT 70 ML OF AIR WAS USED TO INFLATE THE BALLOON. AFTER THE MRI WAS COMPLETED THE AIR WAS REMOVED FROM THE BALLOON WITH A SYRINGE AND THE ENDORECTAL COIL WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE NURSE REMOVING THE ENDORECTAL COIL NOTED THERE WAS BLOOD ON THE TIP OF THE ENDORECTAL COIL. SHE NOTICED NOTHING ELSE UNUSUAL WITH THE TIP OF THE ENDORECTAL COIL. THE PHYSICIAN WAS INFORMED, IMAGES WERE REVIEWED AND A POSSIBLE RECTAL TEAR WAS IDENTIFIED. DURING IMAGE REVIEW IT WAS ALSO NOTED THAT THE PATIENT HAD A VERY UNUSUAL SIGNIFICANT TURN IN HIS RECTAL ANATOMY. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT WHERE HE HAD X-RAYS PERFORMING WHICH REVEALED FREE AIR AND A 5 CM RECTAL TEAR. THE PATIENT THEN BEGAN TO

  Patient problems: Bowel Perforation; Patient Problem/Medical Problem; Perforation

  MAUDE report 7723567 ↗