MAUDE Adverse Event Report: COLOPLAST A/S SELF-CATH STRAIGHT TIP FEMALE; SC FEMALE W/LUER END 14FR

Model Number	5019601400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
2 coloplast catheters were utilized by the end user which will be filed under separate mfr#'s.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, a female end-user informs that during the last year she has had 10 urinary tract infections (utis) and 19 hospital stays due to catheterising.During the last 30 years she has had recurrent utis and hospitalization.The end-uses states that it is not a problem with the catheters, they are not defective.The end-user also informs that she has been hospitalized overnight many times over the years of catheterizing and she has seen many doctors about how to stop the uti's from happening, but no solution has been found yet.No additional information was provided.

• Brand Name: SELF-CATH STRAIGHT TIP FEMALE
• Common Device Name: SC FEMALE W/LUER END 14FR
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 11802686
• Report Number: 3005945907-2021-00003
• Device Sequence Number: 3659572
• Product Code: EZD
• UDI-Device Identifier: 05708932575690
• UDI-Public: 05708932575690
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: 5019601400
• Device Catalogue Number: 50196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/10/2021
• 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: Hospitalization