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

Model Number	2841401400
Health Effect - Clinical Codes	Anemia (1706); Pain (1994); Urinary Retention (2119); Blood Loss (2597)
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 patient could urinate before the doctor gave him something.He was given potassium after surgery.Later that night, the patient couldn't urinate for a couple of days and nights.He was in pain and went to the er.They put a catheter in and the patient was able to go home.The patient was still experiencing pain and returned.His urologist removed the catheter (foley).He was bleeding because of all the trouble of removing that foley.The patient was supposed to be using a coudé and not a straight.There was blood as a result this and the patient was given 6 units of blood.He had seizures due to so much blood loss due to anemia.The hospital staff commented that they did not suspect any device failure.

• 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: 8604630
• Report Number: 3006606901-2019-00009
• Device Sequence Number: 2359601
• 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: Not provided
• 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