MAUDE Adverse Event Report: ROI CPS, LLC REGARD; UNIVERSAL CUSTOM PACK

Model Number	880429002
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Tears noted in both the vented bag and back table cover before opening pack for use.Pack was removed and a new pack was opened for case.

• Brand Name: REGARD
• Common Device Name: UNIVERSAL CUSTOM PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 17039812
• Report Number: 3014527682-2023-00007
• Device Sequence Number: 6515521
• Product Code: LRO
• UDI-Device Identifier: 10194717112389
• UDI-Public: 10194717112389
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: Other
• Device Expiration Date: 11/15/2024
• Device Model Number: 880429002
• Device Catalogue Number: 880429002
• Device Lot Number: 95553
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (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