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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT
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ALCON - HOUSTON CUSTOM PAK; CONVENIENCE KIT Back to Search Results
Model Number CUSTOM PAK
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2014
Event Type  malfunction  
Event Description
A customer reported that the light source would not fit through the trocar during surgery.An alternate light source was used to complete the case.There was no harm to the patient.
 
Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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.(b)(4).
 
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Brand Name
CUSTOM PAK
Type of Device
CONVENIENCE KIT
Manufacturer (Section D)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer (Section G)
ALCON - HOUSTON
9965 buffalo speedway
houston TX 77054
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth, TX 76134
8176152742
MDR Report Key3998888
MDR Text Key4779594
Report Number1644019-2014-00122
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2016
Device Model NumberCUSTOM PAK
Device Catalogue NumberCUSTOM PAK
Device Lot Number1596161H
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/24/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
23GA W/RFID; ILLUMINATED PIK; CONSTELLATION VISION SYSTEM
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