MAUDE Adverse Event Report: TIDI Products LLC ZERO GRAV HINGD MONORAIL SYSTM; Apron, Leaded

Model Number	ZGCM-HSA
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction

• Brand Name: ZERO GRAV HINGD MONORAIL SYSTM
• Common Device Name: Apron, Leaded
• Manufacturer (Section D): TIDI Products LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; +1(920)751-4300
• MDR Report Key: 50892132
• Report Number: 2182318-2026-00109
• Device Sequence Number: 10711914
• Product Code: EAJ
• UDI-Device Identifier: 00618125176144
• UDI-Public: 00618125176144
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: User Facility
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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
• Device Model Number: ZGCM-HSA
• Device Catalogue Number: ZGCM-HSA
• Device Lot Number: 657277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown