MAUDE Adverse Event Report: ROI CPS, LLC REGARD; C-SECTION PACK

Model Number	LD00358P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tape stuck to basin wrap created hole in sterile field.Case was emergent, so facility covered hole with sterile or towels and completed case.
Additional Manufacturer Narrative
There was insufficient information provided by the end user facility, so the cause of the hole is unknown at this time.The basin wrap contains a tear here label that if torn at the perferation will prevent damage to the wrap.There is no other tape supplied with or as part of the kit that could cause the type of damage reported.A sample was not provided for investigation.

• Brand Name: REGARD
• Common Device Name: C-SECTION 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: 16907656
• Report Number: 3014527682-2023-00006
• Device Sequence Number: 6819593
• Product Code: OHM
• UDI-Device Identifier: 10194717116424
• UDI-Public: 10194717116424
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: LD00358P
• Device Catalogue Number: 800205016
• Device Lot Number: 94402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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