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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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MEDOS INTERNATIONAL SàRL FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284002
Device Problem Increase in Pressure (1491)
Patient Problem Not Applicable (3189)
Event Date 01/10/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). Udi: (b)(4).
 
Event Description
It was reported by affiliate via phone that during a knee arthroscopy the fms vue pump needed a diagnostic test to be able to assess functionality. There was a 20 minutes surgical delay and also a patient consequence that caused fluid absorption in quadriceps. Also during the procedure the pump had to be change. The procedure was completed using an alternative product. No additional information was completed.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9593020
MDR Text Key185520026
Report Number1221934-2020-00217
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284002
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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