MAUDE Adverse Event Report: TIDI PRODUCTS LLC POSEY BED TENT AND FRAME; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number	A8070TF
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient escaped canopy through hole in netting.No injuries of patient or staff were reported.
Additional Manufacturer Narrative
The product will not be returned.The canopy was disposed of by the customer; therefore, this event is reported based solely on information provided by the customer.The reported issue was confirmed through customer-supplied photographs and the completed questionnaire.The customer reported that the patient damaged the netting of the canopy, creating a hole and subsequently escaping through that hole.The customer also noted that this patient has damaged prior canopies.No injuries to the patient or staff were reported.Posey beds are multi-use items.As part of standard care, the units are expected to undergo routine inspection prior to patient use.If any damage is observed during these inspections, the bed should be removed from use and returned to posey for evaluation and replacement.The instructions for use (ifu) were reviewed and determined to provide adequate warnings and guidance for the safe and effective operation of the device.All complaints are tracked and reviewed by management on a monthly basis.During these reviews, any trends or excursions beyond control limits are assessed, documented, and addressed as appropriate.At this time, no corrective or preventive actions are required.Manufacturer reference file: (b)(4).

• Brand Name: POSEY BED TENT AND FRAME
• Common Device Name: PATIENT BED WITH CANOPY/RESTRAINTS
• 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: 24205555
• Report Number: 2182318-2026-00013
• Device Sequence Number: 13167974
• Product Code: OYS
• UDI-Device Identifier: 10190676000996
• UDI-Public: 10190676000996
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2026

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?: Yes
• Device Model Number: A8070TF
• Device Catalogue Number: A8070TF
• Device Lot Number: 4142T113
• 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: 01/26/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown