MAUDE Adverse Event Report: CONVATEC Cure Catheter®; CURE CATHETER® FOR MEN & WOMEN

Model Number	510863
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reported multiple uti's while using the cure f14 catheter throughout her life, unknown lots, unknown mu/s, unknown qty.Consumer has been using this product cure f14 nearly all her life she said as she was born with spina bifida and the need for catheterization via her urethra.Call was kept brief as she had to get to an appointment.She said twice she doesn't think her utis are caused by the catheters but rather the conditions she has.Consumer said her chronic utis have caused her multiple hospital stays, treated with antibiotics most recently as a week ago.She said her utis have been more frequent lately but have occurred all throughout her life.She said her utis are always checked by her md with urine testing and this is how she is diagnosed with utis.She was born with spina bifida and has been cathing all her life, mostly 7 x a day sometimes more or less depending on how much water she drinks.We explored her catheterization technique and she often still uses the catheter if it becomes unsterile prior to insertion.Often it will touch the counter and then she will wipe the catheter itself down with a baby wipe prior to insertion.She said she has never used lubricant before either.I reminded her the importance of keeping the catheter as sterile as possible prior to insertion to prevent uti.She was appreciative of the reminder.She does make sure to wash her hands prior to cathing, wipes her urethra with a baby wipe and sometimes she will use gloves as well.She denies any history of kidney stones/bladder stones.She is aware her chronic constipation can put her at risk for utis and she is working with her md to prevent this as well.She said she is following up with her md for this and they recently recommended a supplement which she just purchased as well and will start.She said she has tried multiple catheter samples in the past and prefers her cure f14.She does not like closed systems.Denies any alternative samples at this time.No photo available.Lot number information has been confirmed and no additional lot number information is available.
Additional Manufacturer Narrative
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.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: (b)(4).Manufacturing site: (b)(4).

• Brand Name: Cure Catheter®
• Common Device Name: CURE CATHETER® FOR MEN & WOMEN
• 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: 15275134
• Report Number: 1049092-2022-00315
• Device Sequence Number: 12381817
• Product Code: KOD
• UDI-Device Identifier: 00815947020215
• UDI-Public: 00815947020215
• Combination Product (Y/N): N
• 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

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: 510863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/23/2022
• 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: Female