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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 Break (1069)
Patient Problem Not Applicable (3189)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer 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 (b)(6) that during an unknown surgery on (b)(6) 2020, it was observed that part of the footswitch device had been broken. A spare device was used to complete the procedure with a 30 minute delay. There were no adverse patient consequences 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 Key10854173
MDR Text Key216961945
Report Number1221934-2020-03519
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2020
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 Manufacturer11/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
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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