MAUDE Adverse Event Report: TIDI PRODUCTS LLC GL LARGE FOLEY 10PK ST; HOLDER, URETERAL CATHETER

Model Number	3400LFC-10PK
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: because the complaint originated as an amazon review, information is very limited.Amazon will not provide their customer's contact information.There is no lot information available and the specifics of use of the device (what type or size of tube/device was being secured, was the product applied per the ifu etc.), are unknown.Without additional information, the complaint cannot be confirmed, nor can root cause be positively determined.Based on historical complaint data, possible root cause is related to new users and device training.As this device is likely being used by end users in a home setting, they may not be following the instructions for use and proper application protocol.(b)(4).Therefore, no further corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file (b)(4).
Event or Problem Description
Amazon review: i used the 1st of these yesterday; it didn't even last 12 hours before it totally came off.I even used a barrier cream that is supposed to help it stick better.Today i decided i'd let it set longer before i hooked my catheter tubes in it.Within an hour, it was already coming loose.

• Brand Name: GL LARGE FOLEY 10PK ST
• Common Device Name: HOLDER, URETERAL CATHETER
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 21020174
• Report Number: 2182318-2024-00174
• Device Sequence Number: 8342491
• Product Code: EYJ
• UDI-Device Identifier: 00618125134786
• UDI-Public: 00618125134786
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 12/11/2024

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 Model Number: 3400LFC-10PK
• Device Catalogue Number: 3400LFC-10PK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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