MAUDE Adverse Event Report: CONVATEC CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M18
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
Consumer stated 'had a lot of bleeding that caused a 2 day hospitalization and foley catheter'.He has been cathing for about 25 years about 4 x a day and he is paralyzed has no feeling in his bladder.Consumer stated the bleeding was due to a recent different tip describing a coude tip that caused him this bleeding.He was not sure why he was switched to coude and he had no idea about how to insert the tip properly stating "i would insert it any old way" prior to bleeding episode as he was never instructed on how to catheterize properly with coude tip.He thinks the tip is what caused him the bleeding episode.A little over a month ago he said he was at a routine md check up appt after he had recently cathed that day and he told his md he had been having a large amount of bleeding after he had catheterized, he said his entire diaper was "full of blood" after that cath.That md admitted him to hospital where they placed a foley in him and irrigated him well until bleeding stopped.He stayed in hospital for 2 days and then sent home with foley for a month.About a week and half ago he went into his urologist to follow up and a cysctoscopy was done and "he couldn't find anything wrong." they sent him him home to resume cathing.
Additional Manufacturer Narrative
D2a: common device name: catheter, urological based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 3005471919.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16776140
• Report Number: 1049092-2023-00048
• Device Sequence Number: 20580656
• Product Code: KOD
• UDI-Device Identifier: 00815947021083
• UDI-Public: 815947021083
• Combination Product (Y/N): N
• Initial Reporter State: IN
• PMA/510(K) Number: K080881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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: 02/28/2025
• Device Model Number: ULTRA M18
• Device Lot Number: 220326-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male