MAUDE Adverse Event Report: CONVATEC GENTLECATH GLIDE; CATHETER, URETHRAL

Model Number	421567
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.Fda registration number reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
End user reports "several" from "a couple boxes" unknown qty mu boxes, unknown lots in recent order arrived with catheters bent/ twisted in packages upon removal from boxes and use caused one to be stuck in his resulting in bleeding and a uti.End user is a 63 yr old male cathing for many years for retention from bph - caths 6-7 times a day.Long time user of this product.He said in a recent order many of the catheters he received, when he removed them from the mu boxes they were "twisted and bent." he said they were uncomfortable to use because of these twists and bends but since he had nothing else to use he had to use them anyway to cath with to empty his bladder.He said he had significant injury with use of 1 stating it got stuck inside of him due to the bend nearer to the tip area in the catheter.He said he tried to pull it out of him after he had drained but it would not come out.He kept trying to get it out pulling gently little by little, but it became more difficult as the time went on as the catheter was drying out and sticking inside of his urethra.He said he finally got it out after nearly 1 -2 hours of him trying to get it out.Upon removal, he had constant bleeding out of his penis dripping stating it was a "lot of blood" he said for a "few days" and burning in his urethra.He was able to see his urologist because of this who also ran a urine culture, and it showed he had e.Coli and gave him an injection of rocephin (no oral antibiotics).He reports the bleeding has stopped but he is still sore in his urethra.No photo available as they have been discarded - no photos.
Additional Manufacturer Narrative
Investigation: 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, sop-000741.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): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 7815 national service road; suite 600; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 6032470255
• MDR Report Key: 24023797
• Report Number: 1049092-2026-00002
• Device Sequence Number: 8952384
• Product Code: GBM
• UDI-Device Identifier: 30768455143543
• UDI-Public: 30768455143543
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 01/05/2026

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: 421567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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 Age: 63 YR
• Patient Sex: Male