MAUDE Adverse Event Report: CONVATEC L3C0600 - CURE PRODUCTS

Model Number	510819
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
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.Fda registration number (b)(4).
Event or Problem Description
End user reports multiple utis over the last year, about every 6 months he said, last one in (b)(6) 2022 while using these catheters.When asked if he thinks the catheters are the cause of his previous utis he said he isn't sure.He said his doctor put him on a daily low dose prophylactic antibiotic after his last uti in feb/march and he does not know the name of it, but it has been working to prevent further utis since his last uti in feb/march and still uses these catheters.He said he is always mindful to wash his hands prior to cath use, if they touch anything and become unsterile he throws them away and he does wipe prior to insertion with an antibacterial wipe.His symptoms that indicated he was having a uti were always foul odor, irritation, fevers, and trouble urinating (small frequent amts), burning.He said he always went to do a urine sample and his doctor found eat time that he was positive for uti and they prescribed him an antibiotic courses each time before being placed on current low dose daily antibiotic.He has been using these catheters for a little less than the full year he has been cathing.He said he had trialed other catheters before choosing the ultram18c.He caths 4 x a day.He said he has had surgical procedures to open his bladder neck as there has been tightening there, that is why he uses coude tip.He said he also caths due to "bladder muscle being stretched out" denies history of kidney stones.States his bowel movements are always regular too.He is not sure the cause of his utis but happy the low dose prophylactic medication is working to prevent them.Lot number information has been confirmed and no additional lot number information is available.
Additional Manufacturer Narrative
H10 update to correct mfg number.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.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 14596479
• Report Number: 1049092-2022-00296
• Device Sequence Number: 13967593
• Product Code: OHR
• UDI-Device Identifier: 00815947021137
• UDI-Public: 00815947021137
• 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,Followup
• Report Date (Section B): 05/31/2022

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: 510819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/15/2022
• 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