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

Model Number	AA61101002
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
See manufacturer report numbers 9610711-2021-00118 and 9610711-2021-00119 regarding the other two occurrences of balloon burst.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 information 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 the available information, three balloons burst in the pediatric patient¿s bladder when the balloon was blocked with 6 ml.The mother blocks the balloon and had used the product daily for several months.She stated the balloon can be blocked with maximum 15 ml, but it was noted she had not read the instructions for use.The patient was not harmed.
Additional Manufacturer Narrative
See manufacturer report numbers 9610711-2021-00118 and 9610711-2021-00119 regarding the other two occurrences of balloon burst.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 information 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 the available information, three balloons burst in the pediatric patient¿s bladder when the balloon was blocked with 6 ml.The mother blocks the balloon and had used the product daily for several months.She stated the balloon can be blocked with maximum 15 ml, but it was noted she had not read the instructions for use.The patient was not harmed.

• 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: 13019001
• Report Number: 9610711-2021-00120
• Device Sequence Number: 5127413
• Product Code: EZL
• UDI-Device Identifier: 03600040127100
• UDI-Public: 03600040127100
• 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: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/04/2026
• Device Model Number: AA61101002
• Device Catalogue Number: AA6110
• Device Lot Number: 8133788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/16/2021
• Date Device Manufactured: 08/06/2021
• 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
• Patient Age: 10 YR
• Patient Sex: Male