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

Model Number	AA61121002
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to available information, this device was unable to be removed from the patient in a normal fashion because the balloon failed to deflate.It was noted that the doctor was unable to remove the device because it seemed to be adhered to the urinary meatus.A surgeon was able to remove the device while the patient was under anesthesia.
Additional Manufacturer Narrative
One device was used to test it and inflate some air and osmosis water and the deflate it without any abnormality.From experience, silicone balloon deflation could come from various causes.In this cases we can not identify any specific root cause as insufficient information has been provided to do so.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: 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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13568480
• Report Number: 9610711-2022-00029
• Device Sequence Number: 5848758
• Product Code: EZL
• UDI-Device Identifier: 03600040127230
• UDI-Public: 03600040127230
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: AA61121002
• Device Catalogue Number: AA6112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 05/05/2022
• 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: Required Intervention
• Patient Sex: Unknown