MAUDE Adverse Event Report: COLOPLAST A/S UNKNOWN FOLEY; SILICONE FOLEY CATHETER

Device Problem Insufficient Information (3190)

Patient Problems Scar Tissue (2060); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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 additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, this complaint is related to complaint record # (b)(4).In 2014, the end-user was using a straight tip catheter and developed an active bleed.The end-user does not recall the specific date of occurrence.He was admitted to the hospital due to the bleeding.In the hospital a foley catheter was placed, the end-user does not recall the type of foley catheter that was used.While wearing the foley he was passing blood clots and clogging of the foley catheter.The catheter had to be removed and replaced.He had a cat scan and the doctor could not figure out the source of the bleeding.The end-user stated that the doctor assumed the catheter tore tissue and caused the bleeding.The end-user wasn't sure that was the cause because he was having bleeding from the bladder.No further medical intervention to stop the bleeding.Foley catheters were used for a total of three weeks.End-user stated that the foley catheter caused peyronie's disease.He further stated that his doctor informed him that this condition is not unusual with prolonged foley usage.

• Brand Name: UNKNOWN FOLEY
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; 24206 ; FR 24206
• Manufacturer Contact: sarah o'gara ; 1601 west rivier road north; minneapolis,, MN 55411 ; 6123578517
• MDR Report Key: 8601410
• MDR Text Key: 144754771
• Report Number: 9610711-2019-00019
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR