MAUDE Adverse Event Report: MEDLINE INDUSTRIES COUDE TIP - SILICONE ELASTOMER COATED LATEX FOLEY CATHETER

Model Number DYND11216

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Reaction (2414)

Event Date 03/03/2019

Event Type  No Answer Provided  

Event Description

On (b)(6) 2019, a surgical procedure, laparoscopic assisted diverting loop ileostomy completed.Ostomy would not remain open; 18 fr catheter placed to drain bowel and keep ostomy open.Pt allergic to latex.Catheter placed was a coated latex catheter.Observation / monitoring of stoma revealed sloughing skin.

• Brand Name: COUDE TIP - SILICONE ELASTOMER COATED LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES ; mundelein
• MDR Report Key: 8515021
• MDR Text Key: 142217502
• Report Number: MW5085849
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: DYND11216
• Device Catalogue Number: (0110080196726769
• Device Lot Number: 59218050434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 80