MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL SILICONE CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number	AA6116
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the balloon leaked and slips out resulting in a bladder infection.
Additional Manufacturer Narrative
After receiving the complaint, we were unable to searched for other complaints as the lot number is unavailable.Unfortunately, the sample isn't available from our customer.From experience, silicone balloon deflation could come from various causes.In this case we cannot identify any specific root cause as insufficient information has been provided.In parallel, a specific trend is monitored regarding the silicone ballon issue through the capa-000152 checking the quality databases revealed this type of defect is known and closely monitored.A similar case study was performed based on the same item number, defect balloon problem over last four years, 89 similar cases were found.A risk management file evaluation was performed and concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: FOLYSIL SILICONE CATHETER
• Common Device Name: INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat-la-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18751859
• Report Number: 9610711-2024-00044
• Device Sequence Number: 3703641
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 3600040127490
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AA6116
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown