MAUDE Adverse Event Report: UNOMEDICAL S.R.O. GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421910
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
A2: age - 81 years a3: sex - female 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: 1049092 manufacturing site: 3005471919.
Event or Problem Description
End user reports she has history of multiple diagnosed utis while using this product over the past 2-3 yrs.She states "i am not blaming your product (ultra16) for the utis, i blame my body." she is an 81 yr old female with history of spina bifida/ tethered cord diagnosed in her 40s.She states she has been catching for 45 yrs now 7 x day and she said even before catching she was always prone to utis.She got an illeostomy in 2015 and since then, she said she has gotten even more frequent utis and does not know why.She caths through her urethra.She said she gets utis every 2 months or even more frequently saying she gets her urine checked (ua / urine culture) about twice a month for uti symptoms and often it is positive for uti and needs antibiotic treatment; stating in the past she has been on every antibiotic and even bladder antibiotic installations (not sure of name) in the past and utis keep returning; stating it will clear up and often then 3-4 days later it returns feeling like she can never rid of her utis.
Additional Manufacturer Narrative
Correction: d1: brand name - cure products.D2b: product code - gbm.D4: model number - ultra 16.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: GENTLECATH GLIDE
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; suite 600; michalovce NC 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; suite 600; michalovce NC 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19115161
• Report Number: 1049092-2024-00036
• Device Sequence Number: 20614896
• Product Code: GBM
• UDI-Device Identifier: 00815947020451
• UDI-Public: 00815947020451
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 421910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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: Unknown