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

Model Number	421571
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user states "she caths due to retention from bladder muscle dysfunction.She caths 6-7 x a day and is not new to cathing.She previously used the cure t10 without concerns and then due to insurance reasons was switched to the gc glide 10 fr female.Gc glide initially worked well for months but she has noticed a change in the last 2 months only they are not working well for her.She states since she started to notice the color of the catheter change to yellow" (it was explained to her that change was made due to the change in sterilization process).End user states "they feel dry/ inadequate lubrication after activation of water sachet.She said after she finally removes the catheter from urethra she will run her hand down them and they all feel dry affecting the entire catheter even near eyelets.Often they will "get stuck" in urethra as she removes them out which previously would never occur with these.She said it sometimes has caused her pain to the point of crying.She ensured she uses them within the 1-2 time frame after the water sachet is burst to drain herself.In october, this pain did not subside.Pain and irritation increased so she went into urgent care where they did a urine sample and she was diagnosed with a uti and treated with antibiotics.She said her symptoms never fully resolved so in november she went into for another urine sample and she did say the culture showed a different bacteria than october's urine sample (could not relay the name) and so she was treated with antibiotics again and even needed iv antibiotics.She said between oct/nov she had 4 different antibiotics, one she said was cefdinir and the other possible vancomycin.She said she last finished these up a few days ago.She still feels irritation in her urethra now but overall better than prior.During the time she had utis she did not use the estradiol cream she normally uses 2 x a week.She has followed up with infectious disease, she is following up with urology soon for this.She has been doing pelvic floor therapy as well for the last couple months.Denies recent constipation with diet she has been placed by gi.She said she has seen 2-3 urogynecologists, she does not have prolapse she is aware of.Prior to this change she has noticed in the gc glide she did not get frequent utis, she said "every once in a while." she is very good about washing hands, ensuring the catheter stays sterile prior to insertion and does wipe her urethra prior to insertion." this emdr covers the unknown number of catheters associated with the utis.
Additional Manufacturer Narrative
A2: age: 65, sex: female.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: 3005778470.
Additional Manufacturer Narrative
Review of the dhr showed that all relevant tests required during the manufacturing and packaging process and final product release had been fulfilled and met the requirements.No nonconformity had been registered during the production process of the mentioned lot.A query was run against lot 2m00530.No another complaint of this nature was received on the lot.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 3005778470.
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,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18237173
• Report Number: 3005778470-2023-00353
• Device Sequence Number: 19640161
• Product Code: GBM
• UDI-Device Identifier: 30768455143574
• UDI-Public: 30768455143574
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: K161344
• 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): 11/28/2023

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: 11/01/2025
• Device Model Number: 421571
• Device Lot Number: 2M00530
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown