MAUDE Adverse Event Report: OASIS MEDIKAL ÜRÜNLER KIMYA TURIZM SAN. VE TIC. A. GENTLECATH HYDROPHILIC; HYDROPHILIC CATH MALE CH14X16 INCH

Model Number	508995
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not available to be returned.Without the benefit of examination and testing, oasis medikal is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
A 64 year old male patient, using the subject catheter about a year, 4 x a day due to enlarged bladder/ bladder atony without concerns using this product.At the end of (b)(6) 2023 for second time he noticed his catheters had a defect which he believes caused him a uti while using them.Patient claiming, in (b)(6) 2023 he noticed when he would activate the sterile water "big chunks" of the white coating (the hydrophilic coating)" floating around in the sleeve.He also saw that parts of the catheter were "more clear" than normal as well, like the coating was coming off in pieces after activation.He used the catheter and had no pain at all while using it but then shortly after that he got a uti and he thinks this defect is why.He had irritation, burning frequency urgency bladder cramping and had to go to md and did get urine testing and uti diagnosed.He did have an antibiotic prescribed which helped this symptom.He described the issue of the catheter to his md and his md told him not to use any with the concern.Prior to this he had used this catheter and never saw this occur after activation.

• Brand Name: GENTLECATH HYDROPHILIC
• Common Device Name: HYDROPHILIC CATH MALE CH14X16 INCH
• Manufacturer (Section D): OASIS MEDIKAL ÜRÜNLER KIMYA TURIZM SAN. VE TIC. A.; fatih mah. 3105; cad. no:8 06980; kazan/ankara, ; SW
• Manufacturer (Section G): OASIS MEDIKAL ÜRÜNLER KIMYA TURIZM SAN. VE TIC. A.; fatih mah. 3105.; cad. no:8 06980; kazan/ankara ; TU
• Manufacturer Contact: emad ramzi ; aminogatan 1; p.o. box 14; mölndal SE-43-121 ; SW SE-43121
• MDR Report Key: 18380127
• Report Number: 3006553489-2023-00002
• Device Sequence Number: 18094187
• Product Code: EZD
• UDI-Device Identifier: 00768455142637
• UDI-Public: 00768455142637
• Combination Product (Y/N): N
• PMA/510(K) Number: K062444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2025
• Device Model Number: 508995
• Device Catalogue Number: 508995
• Device Lot Number: 632347
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: White