MAUDE Adverse Event Report: UNOMEDICAL S.R.O. CURE PRODUCTS; CATHETER, UROLOGICAL

Model Number	ULTRA M14
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: sex - male.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 reported, he recently was diagnosed with a uti as he had bleeding with cathing that lasted said 4 -5 days.He said he had bleeding after meeting some resistance right before entering his bladder with the catheter and it got irritated started bleeding.He went into md office after those 4 or 5 days of bleeding and they did a cystoscopy and he said they cauterized the area that was bleeding.They also diagnosed him with a uti.His md started him on daily gentamicin installations he places his in bladder.No additional information was provided.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 18985776
• Report Number: 1049092-2024-00030
• Device Sequence Number: 8381920
• Product Code: KOD
• UDI-Device Identifier: 00815947021069
• UDI-Public: 00815947021069
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• 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
• Report Date (Section B): 03/21/2024

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: ULTRA M14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/27/2024
• 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