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); Anxiety (2328)

Event Date 09/07/2022

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, this device required removal due to infection.The patient was hospitalized 2 times prior and believes there is an issue with sterility with the device.Patient suffered from severe infection and cellulitis.On 09/07/22 the patient had a device removed and disposed of.The nurse wasn't able to replace the device and attempted 3 times but the device kept curling up in the urethra.On 09/08/22 the device was placed in the morning but the patient started to feel unwell.In the evening the nurse advised the device was blocked.The device was flushed and a lot of sediment was removed along with a lot of blood.The patient continued to feel unwell.On 09/11/22 the patient was hospitalized with a 40 degree celsius fever and was expected to stay for about 2 weeks.Patient reported that microbiology tested his urine and the devices and said there was infection on the device.Patient is worried about getting another infection or cellulitis after device placement.

• 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: 15555711
• MDR Text Key: 301333071
• Report Number: 9610711-2022-00077
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2022

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 Model Number: AA8A161002
• Device Catalogue Number: AA8A16
• Device Lot Number: 8452924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/06/2022
• Date Device Manufactured: 02/23/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male