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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROI CPS, LLC REGARD; NEURO PACK
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ROI CPS, LLC REGARD; NEURO PACK Back to Search Results
Model Number NU00096AJ
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 02/15/2023
Event Type  malfunction  
Event Description
Custom packs were discovered with cuts in them, causing contamination of pack.Customer indicated that there were potentially 3 lots.Packs were discarded and new packs were pulled from sterile supply.Customer did not provide pictures or return samples for investigation.There was no patient contact.
 
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Brand Name
REGARD
Type of Device
NEURO 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 Key16491717
MDR Text Key310791333
Report Number3014527682-2023-00003
Device Sequence Number1
Product Code OJG
UDI-Device Identifier10194717114024
UDI-Public10194717114024
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/06/2023
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 Model NumberNU00096AJ
Device Catalogue Number880096036
Device Lot Number94840,95255,94935
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2023
Initial Date FDA Received03/06/2023
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 Number1
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