MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH CH14 MALE; CATHETER, URETHRAL

Model Number	2841401400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Code Available (3191)
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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
This case concerns a (b)(6) year-old man (2018), who 10 years previously started intermittent catheterization in 2008 due to "extended bladder", under the guidance of his doctor.In 2014 - using speedicath straight- he developed a bleed (urethra?/bladder?) which led to 2 weeks of hospitalization, blood transfusion and placement of a foley catheter for 3 weeks; a cat scan did not disclose the site of bleeding and the doctor assumed that the reason for bleeding was incorrect use of the speedicath catheter.Subsequently he was switched to a coudé catheter and later he developed peyronie´s disease, which according to the treating physician was due to the prolonged use of the foley catheter.No further relevant info regarding this case from 2014.Conclusion: bleeding episode described in connection to speedicath straight use in 2014 leading to 3 weeks placement of a foley catheter.Reason for subsequent development of peyronie´s disease unclear, but assessed to be related to use of foley catheter.

• Brand Name: SPEEDICATH CH14 MALE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 8604631
• Report Number: 3006606901-2019-00008
• Device Sequence Number: 19381487
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2019

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: 2841401400
• Device Catalogue Number: 2841401400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/13/2019
• 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: Other
• Patient Age: 73 YR