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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD FLEXON ELECTRODE, PACEMAKER, TEMPORARY

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DAVIS & GECK CARIBE LTD FLEXON ELECTRODE, PACEMAKER, TEMPORARY Back to Search Results
Model Number 88862589-63
Device Problem Detachment of Device or Device Component
Event Date 01/07/2019
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, during the procedure, after penetrating through the tissue, the needle and the thread disengaged easily. The procedure was completed with another device. There was no patient injury.

 
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Brand NameFLEXON
Type of DeviceELECTRODE, PACEMAKER, TEMPORARY
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven , CT 06473
2034925563
MDR Report Key8284610
Report Number9612501-2019-00160
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number88862589-63
Device Catalogue Number88862589-63
Device LOT NumberD7D2533X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/30/2017
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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