MAUDE Adverse Event Report: COLOPLAST A/S SELF-CATH STRAIGHT TIP MALE; FREEDOM SELF-CATH NELATON CH14

Model Number	5045301400
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Tissue Breakdown (2681)
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 the available information, this complaint describes an event where an end-user (female) of unknown age was harmed.The complaint is filed by the end-user¿s family, as the end-user herself is a minor.The event is described as the catheter breaking and leaving the tip inside the end-user¿s body and two surgeries were needed to remove the tip.The end-user was finally discharged the 2nd of june.The first surgery required 1 overnight stay at the hospital, and the second a 2-night stay.It is unclear what type of surgery was performed, why the second one was needed, and what harm was caused.The reason for the catheter breaking is not known, there are no indications of the product being faulty, and it is unknown whether the product was used according to the instruction for use.The reason for needing intermittent catheterisation and the family¿s experience with intermittent catheters is not stated.Also, the reason for the female end-user using a male-catheters is not clear.Child protective service is stated to be involved, but not for what reason.No further information is available.

• Brand Name: SELF-CATH STRAIGHT TIP MALE
• Common Device Name: FREEDOM SELF-CATH NELATON CH14
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST (CHINA) LTD.; no.202, bao cheng rd; xiang zhou distric; zhuhai 51903 0; CH 519030
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 14744221
• Report Number: 3005945907-2022-00002
• Device Sequence Number: 6777779
• Product Code: EZD
• UDI-Device Identifier: 05708932576307
• UDI-Public: 05708932576307
• Combination Product (Y/N): N
• PMA/510(K) Number: K100878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5045301400
• Device Catalogue Number: 50453
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/20/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Female