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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. AVID MEDICAL NEURO PACK NEURO KIT / NEUROLOGICAL TRAY

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OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC. AVID MEDICAL NEURO PACK NEURO KIT / NEUROLOGICAL TRAY Back to Search Results
Catalog Number VMCI024-06
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 07/26/2018
Event Type  Injury  
Event Description
We have had 2 neuro kits from avid medical come with bugs in the wrappers. In one a dead mosquito was in the foam insert lot number 1306444, and in another neuro pack lot number 1306444 there was a life flea that came out of the pack.
 
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Brand NameAVID MEDICAL NEURO PACK
Type of DeviceNEURO KIT / NEUROLOGICAL TRAY
Manufacturer (Section D)
OWENS AND MINOR DISTRIBUTION, INC. / AVID MEDICAL INC.
MDR Report Key7776636
MDR Text Key117025698
Report NumberMW5079064
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/10/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2019
Device Catalogue NumberVMCI024-06
Device Lot Number1306444
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2018 Patient Sequence Number: 1
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