NON-ADHESIVE CONDOM CATHETER

Description of Event or Problem

THE PATIENT DEVELOPED A PRESSURE ULCER ON HIS PENIS ON A UNKNOWN DATE. THE CATHETER WAS REMOVED FROM THE PATIENT. A NEW CATHETER WAS NOT USED ON THE PATIENT. ACCORDING TO THE INITIAL REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE, DUE TO HIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

LOT # IS UNKNOWN AS IT WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. UDI # IS UNKNOWN AS NO LOT # WAS PROVIDED. (B)(4). DEVICE MANUFACTURE DATE: UNKNOWN AS NOT LOT # WAS PROVIDED. EVENT EVALUATION: DURING THE COURSE OF INVESTIGATION, A PERSONNEL INTERVIEW ALONG WITH A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL WAS CONDUCTED. AS THE PRODUCT WAS NOT RETURNED TO ASSIST IN THE INVESTIGATION, A PHYSICAL EXAMINATION OF THE DEVICE COULD NOT BE COMPLETED. THE DISTRICT MANAGER COMPLETED AN IN-SERVICING FOR THIS EVENT AT THE FACILITY IN QUESTION. INFORMATION RECEIVED AT THE IN-SERVICING INDICATES THAT THERE WAS A SIZING ISSUE FOR THAT PARTICULAR PATIENT. THIS DEVICE IS A REUSABLE DEVICE; WHICH THE PATIENT REMOVES AND PLACES DAILY. AS INDICATED BY THE IN-SERVICING, THE PRESSURE ULCER IS MOST LIKELY THE RESULT OF A SIZING ISSUE WITH THE PATIENT IN QUESTION. SHOULD THE DEVICE BE THE INCORRECT SIZE, THE PATIENT MAY EXPERIENCE PAIN DUE TO THE INCREASED PRESSURE RESULTING FROM A SMALLER SIZE THAN REQUIRED. THE IFU INSTRUCTS THAT "IF ANY UNUSUAL SKIN IRRITATION, DISCOLORATION, LOCALIZED SWELLING OR PAIN, THE USER SHOULD CONTACT THE PHYSICIAN IMMEDIATELY." THE END USER IS INSTRUCTED BY THE PHYSICIAN AS TO HOW TO PROPERLY MAINTAIN AND USE THE DEVICE, AND SHOULD USE THE PRODUCT ONLY AFTER RECEIVING COMPLETE INSTRUCTIONS FROM A PHYSICIAN AND HAS A COMPLETE UNDERSTANDING OF THE PRODUCT AND INSTRUCTIONS. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE HAS BEEN DETERMINED TO BE PRODUCT USE. AS INDICATED BY THE IN-SERVICING AND REPORTED EVENT, THE DEVICE WAS MOST LIKELY THE INCORRECT SIZE FOR THE PATIENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED.

Description of Event or Problem

THE PATIENT DEVELOPED A PRESSURE ULCER ON HIS PENIS ON A UNKNOWN DATE. THE CATHETER WAS REMOVED FROM THE PATIENT AND A NEW REPLACEMENT CATHETER WAS NOT USED ON THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION PROVIDED BY THE SALES REP STATED THAT THIS WAS A SIZING ISSUE FOR THAT PARTICULAR PATIENT AND NOT A PRODUCT MALFUNCTION.

Additional Manufacturer Narrative

(B)(4). THE EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.