Porges Coloplast AEAD35Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450143315), received between May 11, 2017 and Apr 2, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

  ACCORDING TO AVAILABLE INFORMATION, THOUGH NOT VERIFIED, THIS PATIENT EXPERIENCED SYMPTOMS ASSOCIATED WITH PYELONEPHRITIS APPROXIMATELY 24 HOURS AFTER THE INSTALLATION OF THIS PRODUCT FOR A LITHOTRIPSY PROCEDURE. THE DOCTOR NOTED THAT THE CAUSE OF THE INFECTION COULD NOT BE DIFFERENTIATED BETWEEN THIS PRODUCT, THE INSTALLATION PROCEDURE OR HOW THE PATIENT CARED FOR THEMSELVES POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 11611068 ↗
• InjuryApr 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

  ACCORDING TO AVAILABLE INFORMATION, THOUGH NOT VERIFIED, THIS PATIENT EXPERIENCED SYMPTOMS ASSOCIATED WITH PYELONEPHRITIS APPROXIMATELY 24 HOURS AFTER THE INSTALLATION OF THIS PRODUCT FOR A LITHOTRIPSY PROCEDURE. THE DOCTOR NOTED THAT THE CAUSE OF THE INFECTION COULD NOT BE DIFFERENTIATED BETWEEN THIS PRODUCT, THE INSTALLATION PROCEDURE OR HOW THE PATIENT CARED FOR THEMSELVES POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 11611026 ↗
• InjuryApr 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

  ACCORDING TO AVAILABLE INFORMATION, THOUGH NOT VERIFIED, THIS PATIENT EXPERIENCED SYMPTOMS ASSOCIATED WITH PYELONEPHRITIS APPROXIMATELY 24 HOURS AFTER THE INSTALLATION OF THIS PRODUCT FOR A LITHOTRIPSY PROCEDURE. THE DOCTOR NOTED THAT THE CAUSE OF THE INFECTION COULD NOT BE DIFFERENTIATED BETWEEN THIS PRODUCT, THE INSTALLATION PROCEDURE OR HOW THE PATIENT CARED FOR THEMSELVES POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 11611019 ↗
• InjuryApr 2, 2021Microbial Contamination of Device; Microbial Contamination of Device

  ACCORDING TO AVAILABLE INFORMATION, THOUGH NOT VERIFIED, THIS PATIENT EXPERIENCED SYMPTOMS ASSOCIATED WITH PYELONEPHRITIS APPROXIMATELY 24 HOURS AFTER THE INSTALLATION OF THIS PRODUCT FOR A LITHOTRIPSY PROCEDURE. THE DOCTOR NOTED THAT THE CAUSE OF THE INFECTION COULD NOT BE DIFFERENTIATED BETWEEN THIS PRODUCT, THE INSTALLATION PROCEDURE OR HOW THE PATIENT CARED FOR THEMSELVES POST-PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS SUCCESSFULLY TREATED WITH IV ANTIBIOTICS.

  Patient problems: Bacterial Infection

  MAUDE report 11610930 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN ALLEGES THAT POST LITHOTRIPSY PROCEDURE DUE TO UROLITHIASIS, A MEDICAL DEVICE USED DURING THE PROCEDURE MAY HAVE BEEN RESPONSIBLE FOR A HOSPITAL ACQUIRED INFECTION [HAI]. THE PHYSICIAN IS CONSIDERING ALL MEDICAL DEVICES USED DURING THIS PROCEDURE TO BE A POSSIBLE VECTOR OF INFECTION. THE PATIENT WAS ADMITTED 24 HOURS POST PROCEDURE AND ADMINISTERED IV THERAPY ANTIBIOTICS DUE TO PYELONEPHRITIS SYMPTOMS EXPERIENCED.

  Patient problems: Bacterial Infection; Kidney Infection

  MAUDE report 11592479 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN ALLEGES THAT POST LITHOTRIPSY PROCEDURE DUE TO UROLITHIASIS, A MEDICAL DEVICE USED DURING THE PROCEDURE MAY HAVE BEEN RESPONSIBLE FOR A HOSPITAL ACQUIRED INFECTION [HAI]. THE PHYSICIAN IS CONSIDERING ALL MEDICAL DEVICES USED DURING THIS PROCEDURE TO BE A POSSIBLE VECTOR OF INFECTION. THE PATIENT WAS ADMITTED 24 HOURS POST PROCEDURE AND ADMINISTERED IV THERAPY ANTIBIOTICS DUE TO PYELONEPHRITIS SYMPTOMS EXPERIENCED.

  Patient problems: Bacterial Infection; Kidney Infection

  MAUDE report 11592467 ↗
• InjuryMay 11, 2017Break

  ACCORDING TO THE AVAILABLE INFORMATION FROM MEDWATCH MW5068693. DURING THE INSERTION OF GUIDE WIRE, THE END BROKE. PHYSICIAN WAS ABLE TO RETRIEVE PIECE OF THE GUIDE WIRE. SERIOUS INJURY, REQUIRED INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 6561828 ↗