MAUDE Adverse Event Report: MMJ SA DE CV (USD) MON-A-THERM; CATHETER, UROLOGICAL

Model Number	90051
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the device had broken balloon when idc removed on 2 catheters.First idc inserted at start of surgery, no urine output when patient arrived.Second idc inserted and removed as broken balloon.Catheter balloon was tested and found to be leaking.Bladder scan was attended, 650 ml in bladder.Then required 2 idc insertion set ups as 2nd idc balloon broke.The patient experienced pain and discomfort.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: MON-A-THERM
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14497040
• Report Number: 2936999-2022-00463
• Device Sequence Number: 12221666
• Product Code: KOD
• UDI-Device Identifier: 30884521078028
• UDI-Public: 30884521078028
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K831567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: Health Professional
• Device Expiration Date: 03/05/2026
• Device Model Number: 90051
• Device Catalogue Number: 90051
• Device Lot Number: 21C0504JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/25/2022
• Date Device Manufactured: 03/05/2021
• 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
• Patient Sex: Unknown