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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS ENDO CARRY-ON PROCEDURE KIT

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MEDIVATORS MEDIVATORS ENDO CARRY-ON PROCEDURE KIT Back to Search Results
Model Number REF# 102875
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Information (3190)
Event Date 08/18/2017
Event Type  malfunction  
Event Description
A live bat was in endopack upon opening, not used on pt. Sales rep notified, and picked up package that was contaminated.
 
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Brand NameMEDIVATORS
Type of DeviceENDO CARRY-ON PROCEDURE KIT
Manufacturer (Section D)
MEDIVATORS
3150 pollok dr
conroe TX 77300
MDR Report Key6812655
MDR Text Key83507779
Report NumberMW5071742
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2019
Device Model NumberREF# 102875
Device Lot Number87/393/P/33
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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