inforMED
InjuryKOD

FOLYSIL SILICONE CATHETER

Received Sep 22, 2008 · Event occurred Jul 1, 2008

Report 9610711-2008-00005 · MDR key 1171350

Device

Generic name

Silicone Foley Catheter

Model number

AA61161002

Catalog number

AA61161002

Lot number

7113283

Product problems

  • Component Falling
  • Tip breakage
  • Device, removal of (non-implant)

Patient

Not reported

  • Foreign body, removal of
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

ACCORDING TO THE INFO REC'D, A CATHETER TIP FELL OFF THE CATHETER AND REMAINED INSIDE THE BLADDER UPON CATHETER REMOVAL. THE PT UNDERWENT ENDOSCOPIC PROCEDURE TO REMOVE IT.

Additional Manufacturer Narrative

THE RETURN OF THE DEVICE AND ADDITIONAL INFO HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE IS STILL AVAILABLE. AT THIS TIME, NO RESPONSE HAS BEEN REC'D. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADDITIONAL INFO BE REC'D, AN ADDENDUM TO THIS REPORT WILL BE FILED. UPON REVIEW OF THE LOT HISTORY RECORDS, NO DEFECTS WERE NOTED DURING INSPECTIONS. NO ADDITIONAL REPORTS HAVE BEEN REC'D FOR THIS LOT.