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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the available information, this patient had two hospital visits related to the same complaint and therefore two emdrs are being reported - incident numbers (b)(4) and (b)(4).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.
Event or Problem Description
According to the available information, this complaint concerns a male end user who suffers from chronic urinary retention and a significantly enlarged prostate.He has been catheterising for 6 years with a straight tip catheter, but due to his enlarged prostate, he started using speedicath coudé catheters in (b)(6) 2021, after being trained.He experienced bleeding every time and went to the emergency room two times in (b)(6) (the first on (b)(6)2021).There were no apparent defects with the used product (e.G., no sharp or rough edges, adequate lubrication), and it is thus unlikely that the bleeding is related to a product failure.Prior to the first visit, he had lost 2 pints of blood, was dizzy, but did not faint.He received a blood transfusion and stayed in the hospital for 4 days.He received medication in hopes of regaining bladder function, had a foley catheter placed, which was later removed, and went back to intermittent catheterisation.The date and length of the second stay is not known.On (b)(6)2022, he went back to using speedicath standard straight tip catheters.

• 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: 14014344
• Report Number: 3006606901-2022-00010
• Device Sequence Number: 11914608
• 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
• Report Date (Section B): 04/05/2022

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: 12/14/2023
• Device Model Number: 2849401400
• Device Catalogue Number: 28494
• Device Lot Number: 8326960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/05/2022
• Date Device Manufactured: 12/21/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male