MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	510815
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
This emdr is to address the unknown lot numbers.End user reports "he had a month long uti while using these catheters, the ultram14c." he reports unknown number of catheters, unknown number of market units with unknown lot numbers of the same catheter over the last month.He states he doesn't think the catheters are the cause of his uti he thinks his technique needs to get better to reduce his risk for uti.Overall, he said they are "really good catheters" and has no complaints about them." he said he has recently tried to get better about washing his hands prior to cathing as he didn't always used to.He uses the no touch sleeve to keep sterility of the catheter but he doesn't clean his meatus prior to catheter insertion.He said this is the worst uti he has had in his life.He said he had a very "light uti" when he first started cathing that just had malodorous urine and the color was off.This uti about a month ago started off with increased dribbling, felt a lot of pressure in bladder and "gobs of mucous" would come out.He said his testicles also were very inflamed and swollen at beginning of uti symptoms as well however that is getting better now too.He did seek medical attention, urine testing done.He said he has been prescribed 3 different rounds of antibiotics so far this month by his md and the last one he is currently taking (name unknown) is helping the most.He recently had a us bladder/kidney as well ordered by his md and just received results today that showed "when his bladder is full his r kidney is stressed with fluid." he said this recent uti is causing him a lot of pus and it is impeding him placing his catheter as it is so thick in urethra.He said what he has been doing is placing his catheter in part way pulling it out with mucous filling the catheter he washes the mucous out under hot water and then repeats this until he clears the mucous and is able to drain his bladder.He said when he does this, it is irritating to his urethra with all the in/ out of the catheter and with lube washed off especially with this uti.End user was advised this breaks the sterility of the catheter and placing himself at increased risk for uti.He said he knows that it breaks the sterility but he can't afford going through 10 catheters a day.End user was recommended to follow up and let his md know as soon as possible this is happening and what he is doing so a better solution can be found.End user was also reminded about hand hygiene and to talk with his md on what they recommend he use to clean meatus prior to cathing to further prevent uti.He has been cathing for about 1.5 years caused by retention found from many years of previously untreated diabetes which affected his bladder muscle function.He is on insulin now and blood sugars better managed.He typically caths 4 x day.
Additional Manufacturer Narrative
Common device name: cure ultra® ready-to-use catheter for men.Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: CURE PRODUCTS
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15543556
• Report Number: 1049092-2022-00378
• Device Sequence Number: 17551745
• Product Code: KZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• PMA/510(K) Number: K072539
• 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): 09/29/2022

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 Model Number: 510815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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