MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH STANDARD (MALE); SPEEDICATH CH14 TIEMANN

Model Number	2849401400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Hematuria (2558)
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.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
According to the available information, this complaint concerns a male end user diagnosed with benign prostate hyperplasia (bph) (enlarged prostate), causing retention, for which he needs to use catheters.He has been using sc standard coudé (tiemann).Sometimes, he is unable to get the catheter around the prostate, and scratches up against the prostate, which causes bleeding.Upon removal, about 2-3 inches of blood is seen on the catheter tip, but he does not ever have blood in his urine, and no profuse bleeding occurs in between catheterisations.When he experiences bleeding, this is usually also associated with deep pain and discomfort.The pain from using these catheters leaves him feeling too raw and uncomfortable to continue using catheters regularly, and he usually has to wait a couple or few days before using his catheters again.He has a history of developing a uti about every 2 months or so.The last time he scratched his prostate, he ended up in the hospital due to having a urinary tract infection (uti) that became septic.He was admitted to the hospital around on (b)(6)2021 and was discharged on (b)(6) 2022.He had a foley catheter placed and got medication for the infection.When the hospital staff tried inserting the foley catheter, they also came up against a lot of resistance from the prostate, which caused him more pain and discomfort.He has since recovered from this infection, and he takes flomax (a medication used to treat symptomatic bph) regularly to assist with his voiding.
Additional Manufacturer Narrative
The samples have not been returned to manufacturing site for examination.Without the samples, the product defects cannot be confirmed.The relevant production documentation was checked in the database and nonconformity was not revealed, that could be related to the described issue.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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Section h has been updated with the product not returning.Annexes b, c, and d have been changed to reflect this.Additionally, annex g has been updated to include code g04023.

• Brand Name: SPEEDICATH STANDARD (MALE)
• Common Device Name: SPEEDICATH CH14 TIEMANN
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13652399
• Report Number: 3006606901-2022-00005
• Device Sequence Number: 16736679
• Product Code: GBM
• UDI-Device Identifier: 05708932020404
• UDI-Public: 05708932020404
• Combination Product (Y/N): N
• PMA/510(K) Number: K180258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 10/04/2023
• Device Model Number: 2849401400
• Device Catalogue Number: 28494
• Device Lot Number: 8210350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male