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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK GENERAL PURPOSE PROBE, 400 SERIES (+/-0.1C); THERMOMETER, ELECTRONIC, CLINICAL
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DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK GENERAL PURPOSE PROBE, 400 SERIES (+/-0.1C); THERMOMETER, ELECTRONIC, CLINICAL Back to Search Results
Catalog Number 81-020409EU
Device Problem Use of Device Problem (1670)
Patient Problems Perforation (2001); Perforation of Esophagus (2399)
Event Date 10/26/2014
Event Type  malfunction  
Event Description
We received a complaint that the probe passed through the vocal cords, past the trachea and the oesophagus.A ct scan post procedure revealed a small locale of air at the t1 level between the trachea and the oesophagus.
 
Manufacturer Narrative
No further information is available at this time.Will provide follow up if information becomes available.
 
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Brand Name
GENERAL PURPOSE PROBE, 400 SERIES (+/-0.1C)
Type of Device
THERMOMETER, ELECTRONIC, CLINICAL
Manufacturer (Section D)
DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBAL PARK
602 parkway
p.o. box 180-3006
la aurora, heredia
CS 
Manufacturer Contact
8653622322
MDR Report Key4359847
MDR Text Key5238189
Report Number9613793-2014-00008
Device Sequence Number1
Product Code FLL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K925971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 12/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number81-020409EU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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