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

Model Number	2841401400
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
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
According to the available information, the end user used the catheter to cath himself without proper training.The patient stated that he was just given the catheters from a clinician.The patient cathed himself and started bleeding and went to emergency room.The end user said "doctor told the end user to put the catheter through the sperm hole.The patient is now on a foley catheter and is on pain medical.The lot number was not available.

• Brand Name: SPEEDICATH CH14 MALE
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 7299880
• Report Number: 3006606901-2018-00006
• Device Sequence Number: 956746
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K141382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR