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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL
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DEPUY MITEK LLC US FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 283573
Device Problem Increase in Pressure (1491)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional narrative: udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the affiliate in italy that the flow rate on the foot pedal(fms vue/nextra) device was out of range. There was no procedure nor patient involvement reported. No additional information was provided.
 
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Brand NameFOOT PEDAL(FMS VUE/NEXTRA)
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11323272
MDR Text Key231683656
Report Number1221934-2021-00519
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283573
Device Catalogue Number283573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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