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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported by the sales rep via phone that the right side outflow lower lock of the fms vue pump device was not staying in place which affected suction. It was discovered intra-operatively. No patient harm reported. The procedure was shoulder surgery. Another mitek device was utilized to complete the procedure. No further information is provided. It was not reported if a spare device was available for use to complete the procedure. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
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
6103142063
MDR Report Key8124620
MDR Text Key129047268
Report Number1221934-2018-55502
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/22/2016
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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