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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problems Decrease in Pressure (1490); Overfill (2404)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Udi: (b)(4). Initial reporter phone number: (b)(6).
 
Event Description
It was reported by the customer as following: the tubing gradually filled during the procedure. It has been impossible to empty the device without disconnecting the tubing also pressure was inconstant during an unknown procedure. Spare one has been used to complete the procedure. No further information available.
 
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Brand NameFMS VUE PUMP-SHAVER BOX
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 Key10590892
MDR Text Key208714818
Report Number1221934-2020-02767
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
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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