MAUDE Adverse Event Report: COLOPLAST A/S FREEDOM CATH; FREEDON SELF-CATH FEMALE CH12

Model Number	5046201400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	12/04/2020
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
This case involves a (b)(6) female end user.On (b)(6) 2020 at about 10 p.M.She went to the rest room to perform catheterization and immediately felt pain after taking catheter out.About 1 hour later she went to the emergency room where she was diagnosed with possible gall bladder issues.She was admitted to the hospital for a surgical procedure.When the surgery was completed she was informed that her gall bladder was fine, that when they moved the gall bladder to see if there were gall stones present it was observed that her bladder was perforated.The perforation was treated and the patient was placed on a foley catheter until (b)(6) 2020 when it was removed.The physician believed the cause of the bladder perforation was catheterization.The patient is well with no further issues.No additional information was provided.

• Brand Name: FREEDOM CATH
• Common Device Name: FREEDON SELF-CATH FEMALE CH12
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11349632
• Report Number: 3005945907-2021-00001
• Device Sequence Number: 17004179
• Product Code: KNX
• UDI-Device Identifier: 05708932999939
• UDI-Public: 05708932999939
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 5046201400
• Device Catalogue Number: 50462
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR