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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284580
Device Problem Intermittent Continuity (1121)
Patient Problem Not Applicable (3189)
Event Date 08/15/2019
Event Type  malfunction  
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. Udi: (b)(4).
 
Event Description
As stated by the sales rep via phone, the fms duo pump stopped working and two red lights flashed, the case was delayed by 5 mins and completed using another like device. No patient harm.
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO -NS
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 Key8994712
MDR Text Key165993022
Report Number1221934-2019-58251
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2019
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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