MAUDE Adverse Event Report: COLOPLAST A/S SELF-CATH SOFT STRAIGHT TIP MALE

Model Number	5018301400
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Urinary Retention (2119); Hematuria (2558); Dysuria (2684)
Date of Event	12/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information available, this complaint concerns a male end user who had been catheterizing for almost 3-4 years with the self-cath soft catheter prior to the incident.The end user stated that he would usually experience minor bleeding when catheterizing but had a different experience upon the incident reported.The end user felt pain during insertion of the catheter, which he tried to ease by applying more lubricant.It did not help, and the end user reported bleeding to the point that blood went into the catheter tube causing the flow of urine to stop.He was not able to insert the catheter to reach the bladder because of pain in the urethra.The end user was admitted to a hospital for urine retention the end user had later confirmed that he had no symptoms from the bleeding and did recover from it and was admitted in the hospital for 4 days.No further information was provided.
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.

• Brand Name: SELF-CATH SOFT STRAIGHT TIP MALE
• Common Device Name: SELF-CATH SOFT STRAIGHT TIP MALE
• 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: usgab giovanna abugre ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13637952
• Report Number: 3005945907-2022-00001
• Device Sequence Number: 2162961
• Product Code: EZD
• UDI-Device Identifier: 05708932575782
• UDI-Public: 05708932575782
• 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): 03/01/2022

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: Lay User/Patient
• Device Model Number: 5018301400
• Device Catalogue Number: 50183
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 03/01/2022
• 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
• Patient Sex: Male