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

Model Number 421569

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

A2: age 67: sex, male.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.

Event Description

End user states "he has gotten 3 separate utis in the recent past which is not common for him he said." he thinks the sterile water packets are hard to burst open and he thinks this may have caused the utis.It was explained to him that "opening the packaging prior and manipulating the sterile water sachet can compromise the sterility of the catheter and that should be avoided." end user said the "first uti was a month ago and his symptoms are strong urgency, frequency, and sometimes fever.He had to contact his md and did urine testing and his symptoms resolved after treatment with oral antibiotics.He said then 2-3 weeks ago had the same symptoms return, he had another urine test which showed a second uti and more antibiotics and now again for the third time had his symptoms return and had to do the same.He said he had a resolution of symptoms after each antibiotic course.He does not know if they checked his urine after each course of antibiotics when his symptoms resolved.He said he is starting to feel better now as he just started his newest course of oral antibiotics.He does not know if each urine culture of the 3 he had showed different organisms or the same one.He washes his hands prior to cathing, uses the no touch sleeve and cleanses meatus with wipe prior to insertion.".

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 and sterilization process of the mentioned lot.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 1049092.Manufacturing site: 3005778470.

Event Description

To date no additional patient or event details have been received.

• Brand Name: GENTLECATH GLIDE
• Type of Device: 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: 18477114
• MDR Text Key: 332454520
• Report Number: 3005778470-2024-00005
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K181206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421569
• Device Lot Number: 2L03531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1