MAUDE Adverse Event Report: ROI CPS, LLC REGARD; ORTHO EXTREMITY PACK

Model Number	OR00353L
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Tears/cuts in vented bag was identified prior to the kit being brought into the operating room.No patient contact, no harm to patient and no delay to case.Pack was discarded and a new one pulled from inventory.

• Brand Name: REGARD
• Common Device Name: ORTHO EXTREMITY PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• MDR Report Key: 12618748
• Report Number: 3014527682-2021-00017
• Device Sequence Number: 14479067
• Product Code: OJH
• UDI-Device Identifier: 10194717106654
• UDI-Public: 10194717106654
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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: 07/20/2023
• Device Model Number: OR00353L
• Device Catalogue Number: 800200012
• Device Lot Number: 89182L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1