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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L. P. DISCOVERY ELBOW DISC ULNA 3X75MM LT W BRNG C

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ENCORE MEDICAL L. P. DISCOVERY ELBOW DISC ULNA 3X75MM LT W BRNG C Back to Search Results
Model Number 540-00-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
Manufacturer narrative: additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
 
Event Description
2nd revision surgery - due to unknown reason.
 
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Brand NameDISCOVERY ELBOW
Type of DeviceDISC ULNA 3X75MM LT W BRNG C
Manufacturer (Section D)
ENCORE MEDICAL L. P.
9800 metric blvd
austin TX 78758 5445
Manufacturer (Section G)
ENCORE MEDICAL L. P.
9800 metric blvd
austin TX 78758 5445
Manufacturer Contact
teffany hutto
9800 metric blvd
austin, TX 78758-5445
MDR Report Key10503084
MDR Text Key206104987
Report Number1644408-2020-00840
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K013042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/27/2020
Device Model Number540-00-000
Device Catalogue Number114812
Device Lot Number033820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/08/2020 Patient Sequence Number: 1
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