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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON SMALL PART KIT GENERAL SURGERY TRAY (KIT)

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ALCON RESEARCH, LLC - HOUSTON SMALL PART KIT GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number 8065751526
Device Problems Material Discolored (1170); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2019
Event Type  Malfunction  
Manufacturer Narrative

Investigation, including root cause analysis, is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).

 
Event Description

A healthcare professional reported that the sleeve material was softer and a different color; the sleeves did not stand the pressure in the incision. Patient and procedure impact are unknown. The number of patients and devices involved are unknown.

 
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Brand NameSMALL PART KIT
Type of DeviceGENERAL SURGERY TRAY (KIT)
Manufacturer (Section D)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON RESEARCH, LLC - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
jason michaelides
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686438
MDR Report Key9410313
MDR Text Key180359910
Report Number1644019-2019-00186
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK880961
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 01/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065751526
Device LOT Number2256078H
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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