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

Model Number LD00358P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/10/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 315294947
• Report Number: 3014527682-2023-00006
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10194717116424
• UDI-Public: 10194717116424
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1