MAUDE Adverse Event Report: CONVATEC L3C0600 - CURE PRODUCTS

Model Number	510817
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
Common device name: catheter, uretheral.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.(b)(4).
Event or Problem Description
Consumer reports "the ultram16c catheters are always difficult to insert and caused him soreness, pain, and most recently experienced bleeding with them and because of this states because of this they were the cause of his utis".Consumer states this catheters were difficult for him to insert into the entire length of his urethra and he felt particular "pinching" when he got into his bladder sphincters.He said every time he went to use them he never looked forward to it because it was always a uncomfortable experiences and he always felt soreness after cathing that varied in how long it would last, he described it as "progressive pain" for the few weeks he used them most recently.He noted that finally he had " a lot" of blood come out for about 3 days straight every time after he cath'd with these.He said he would note a "portion of a blood coagulation" on the tip of his catheter upon removal and he also noted the urine was mixed with blood and it was dark colored.He said the bleeding stopped immediately after cathing each time.He does take a aspirin 81mg nightly.Because of this bleeding for 3 days after each cath and the pain he felt increased in his urethra stating it was "severe" after cathing on day 3 of the bleeding.He went to see his primary care doctor and she said to stop using these catheters, which he has.He said overall he felt run down and had a low grade fever for a few days.His doctor ran a ua and urine culture and sensitivity and said he had a uti, he is currently finishing up a round of ciprofloxacin antibiotics and is feeling better.He also thinks the tips are different than the catheters he was used to using and this could be part of the difficulty he was having inserting.He said the lubrication was not enough for him either and he tried to place additional sterile lubricant on them but it did not help.He said he was always used to using the bard magic 3 catheters but these were sent as a substitution by his supplier as those were on backorder.He said he never experiences any problems, difficulty, soreness with those catheters.He has these now and he said the soreness and bleeding have stopped.He does wash his hands prior to cathing, placed the coude tip upwards properly and makes sure to use the no touch sleeve.He does not wipe his meatus prior to cathing with an antibacterial wipe.He was advised to do so to prevent uti's.He caths 4 x a day for bph.

• Brand Name: L3C0600 - CURE PRODUCTS
• 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: 14187250
• Report Number: 1049092-2022-00213
• Device Sequence Number: 16876815
• Product Code: OHR
• UDI-Device Identifier: 00815947021120
• UDI-Public: 00815947021120
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• 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): 04/07/2022

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: 03/01/2024
• Device Model Number: 510817
• Device Lot Number: 210412-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male