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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER NRY

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PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER NRY Back to Search Results
Catalog Number 5MAXACE068KIT
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2022
Event Type  malfunction  
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Brand NamePENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
Type of DeviceNRY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key15299136
Report Number3005168196-2022-00391
Device Sequence Number1
Product Code NRY
UDI-Device Identifier00815948022850
UDI-Public815948022850
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K161640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,08/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5MAXACE068KIT
Device Lot NumberH12232
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2021
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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