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

Model Number	5046301400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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 case involves a female patient who states prior to her last order of coloplast catheters, she just had a uti and is convinced that it was from coloplast catheters.The uti placed her in hospital, but it was not reported if intervention was required or what kind of treatment was received.She has been advised that there could be many various reasons for the development of uti's and that she should be speaking to her doctor for treatment plans or different medications that she could potentially take to help prevent them.Attempts have been made to contact the customer, but no additional information could be obtained.

• Brand Name: SELF-CATH STRAIGHT TIP FEMALE
• Common Device Name: SELF-CATH FREEDOM CH14 FEMALE
• 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: 15209202
• Report Number: 3005945907-2022-00003
• Device Sequence Number: 4716990
• Product Code: EZD
• UDI-Device Identifier: 05708932999922
• UDI-Public: 05708932999922
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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: 5046301400
• Device Catalogue Number: 50463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 08/11/2022
• 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: Female