Brand Name | DISCOVERY ELBOW |
Type of Device | DISC ULNA 4X75MM RT 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 Key | 9581588 |
MDR Text Key | 174731205 |
Report Number | 1644408-2019-01328 |
Device Sequence Number | 1 |
Product Code |
JDC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K013042 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/27/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/21/2022 |
Device Catalogue Number | 114823 |
Device Lot Number | 930400 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/18/2019
|
Initial Date FDA Received | 01/13/2020 |
Supplement Dates Manufacturer Received | 01/14/2020 01/14/2020
|
Supplement Dates FDA Received | 02/11/2020 05/27/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/21/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | 114907 LOT 328620; 540-00-000 LOT 75736; 600-10-100 COBALT-G MV BONE CEMENT 40GM; 600-10-100 LOT 810E1D0004; 600-10-100 LOT 810E1D0004; 114907 LOT 328620; 540-00-000 LOT 75736 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 62 YR |
Patient Sex | Female |