MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH FLEX COUDÉ PRO (DOUBLE LOOP)

Model Number	2002402400
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120); Hematuria (2558)
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, this complaint describes an experienced (b)(6) year old male end-user, who after catheterizing with speedicath flex coudé pro experienced bleeding and an urinary tract infection (uti).The end-user was hospitalized for a couple of days, where a foley catheter was placed for 4 days.In addition, the end-user was given antibiotics for 7 days to treat the uti.The end-user had used speedicath flex coudé pro for a couple of years.The end-user states that he did not notice anything sharp or unusual with the catheters, but he was more forceful than normal.The medical doctor stated that he had caused a small cut/wound on his prostate and irritated it.The cut was also stated to have contributed to the uti.The end-user had the foley catheter removed and is interested in continuing to catheterize with another coloplast catheter.The uti cleared up after the antibiotic treatment.No further information was provided.
Additional Manufacturer Narrative
Section h clinical signs and symptoms codes was changed to e0506 vascular system hemorrhage/bleeding.F2301 - additional device required was added to section h health effects ¿ health impact codes.
Additional Manufacturer Narrative
Correction: the device was not returned for analysis.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.
Additional Manufacturer Narrative
Correction: the device was not returned for analysis.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: SPEEDICATH FLEX COUDÉ PRO
• 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: usgab giovanna abugre ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12842351
• Report Number: 3006606901-2021-00032
• Device Sequence Number: 17167236
• Product Code: GBM
• UDI-Device Identifier: 05708932125482
• UDI-Public: 05708932125482
• Combination Product (Y/N): N
• PMA/510(K) Number: K161672
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/14/2022

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 Expiration Date: 01/20/2023
• Device Model Number: 2002402400
• Device Catalogue Number: 20024
• Device Lot Number: 7844998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 10/26/2021; 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/05/2022; 01/10/2022; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2021
• 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 Age: 70 YR
• Patient Sex: Male