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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC FRED 4.5X25X18 FLOW DIVERTER

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MICROVENTION, INC FRED 4.5X25X18 FLOW DIVERTER Back to Search Results
Model Number FRED4518-A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided. A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. The original carton, ifu, and patient implant card were not returned. The pouch containing the device was returned open with a clear imprint of a complete seal on all 4 sides. Besides being opened, the top side presented no anomalies that could have been perceived as a breached seal prior to opening. The investigation of the returned pouch found it to be opened, but it did not display any abnormalities as described in the complaint. The remainer of the packaging was not returned, so it could not be determined if the other packaging components were damaged.
 
Event Description
It was reported that when opening the box containing the device, the package was noted to be poorly sealed. The device was not used in the patient.
 
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Brand NameFRED 4.5X25X18
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC
35 enterprise drive
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key10411640
MDR Text Key203157018
Report Number2032493-2020-00209
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 07/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED4518-A
Device Lot Number19042954H
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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