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

Model Number	2849401400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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, a (b)(6) male experiencing urinary retention due to an enlarged prostate, starting around (b)(6) 2019.He had no previous history of urinary retention or urinary tract infections (utis).A foley catheter was inserted on (b)(6) and removed on (b)(6).As the retention remained, he was trained to use intermittent catheters and was prescribed straight catheters.By mistake, he received one sample of speedicath tiemann (coude) from the doctor's office (not from coloplast) that he used, despite his lack of training in this type of catheter.This resulted in a scratch and some discomfort for a few hours, but he did not have excessive bleeding, and the pain subsided.A few hours later, he went into the emergency room with fever-like symptoms and was hospitalized from (b)(6) to (b)(6).The patient had blood tests and urine samples taken in the emergency room on (b)(6).He was placed on medication (not further specified), which he took for 5 days.By (b)(6), the uti had cleared, and he has not had any further adverse effects.No more follow-up with the doctor's office is needed on this matter, and he is now using straight catheters with no complaints.

• Brand Name: SPEEDICATH CH14 TIEMANN
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9071418
• Report Number: 3006606901-2019-00014
• Device Sequence Number: 14220584
• Product Code: GBM
• UDI-Device Identifier: 05708932020404
• UDI-Public: 05708932020404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 2849401400
• Device Catalogue Number: 2849401400
• Device Lot Number: 5308558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 09/16/2019
• 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: 72 YR