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

Model Number	2841401400
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/20/2017
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, 28414 made end user bleed.Sought medical attention - dr.Told end user it was probably the stiffness of the catheter along with improper use.Dr.Was not concerned and told end user to use a softer catheter.End user was used to using red rubber and would like a similar catheter - sent self-cath soft to try.On (b)(6) 2017 end user indicated that he wasn't used to the stiffer catheter and inserted it too quickly, causing the bleeding.He has learned to insert more slowly, and has gone back to the red rubber catheters until he receives the self-cath soft to try.Things are going better now, and no future problems are anticipated.
Additional Manufacturer Narrative
This follow-up mdr was created to document the updated conclusion codes.

• Brand Name: SPEEDICATH CH14 MALE
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 6291424
• Report Number: 3006606901-2017-00003
• Device Sequence Number: 1503037
• Product Code: GBM
• UDI-Device Identifier: 05708932020275
• UDI-Public: 05708932020275
• Combination Product (Y/N): N
• PMA/510(K) Number: K023254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2017

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: No Information
• Device Model Number: 2841401400
• Device Catalogue Number: 2841401400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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: 83 YR