MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH FLEX COUDÉ PRO (DOUBLE LOOP); SC FLEX 2 BENT TIP D/LOOP CH14

Model Number	2002402400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, this complaint describes an 83-year-old male end user who suffers from bph.After having used sc flex coudé pro only once on (b)(6) 2023, he felt a burning sensation, which kept him from continuing to use catheters.The burning sensation lasted for a couple of weeks, after which he began to urinate blood.This happened twice, and he went to urgent care and was admitted to the hospital, where he stayed for 5 days.He had his bladder irrigated and a foley catheter put in, which was removed after a week.He is not currently using catheters.No further information is available at this time.
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: SPEEDICATH FLEX COUDÉ PRO (DOUBLE LOOP)
• Common Device Name: SC FLEX 2 BENT TIP D/LOOP CH14
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16689022
• Report Number: 3006606901-2023-00008
• Device Sequence Number: 12603160
• Product Code: GBM
• UDI-Device Identifier: 05708932125482
• UDI-Public: 05708932125482
• Combination Product (Y/N): N
• PMA/510(K) Number: K190620
• 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): 04/06/2023

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: 2002402400
• Device Catalogue Number: 20024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/06/2023
• 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 Age: 83 YR
• Patient Sex: Male