MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number AA8A161002

Device Problem Problem with Sterilization (1596)

Patient Problems Cellulitis (1768); Fever (1858); Sepsis (2067)

Event Date 11/01/2021

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 available information, the patient with this device experienced infection, septic fever of 40 degrees celsius, and hospitalization on 3 occasions.The second time the patient was hospitalized was in (b)(6) 2021 for 2 weeks.Also hospitalized in (b)(6) 2021 and (b)(6) 2022.The dates occurred are approximate.All of the catheter placements have taken place in the patient's home.Microbiology tested the patient's urine and device, and they thought infection was on the device.Patient is worried about the sterility of the devices and about future infections.Patient suffers from infection and cellulitis.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15577691
• MDR Text Key: 301523520
• Report Number: 9610711-2022-00079
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2024
• Device Model Number: AA8A161002
• Device Catalogue Number: AA8A16
• Device Lot Number: 7977716
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/11/2022
• Date Device Manufactured: 04/27/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male