Brand Name | BIPOLAR HIP |
Type of Device | SHELL, BIPOLAR, MODULAR, ENCORE, SIZE46 |
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 |
james
mcmohan
|
9800 metric blvd |
austin, tx 78758-5445
|
|
MDR Report Key | 14690236 |
MDR Text Key | 294004354 |
Report Number | 1644408-2022-00777 |
Device Sequence Number | 1 |
Product Code |
KWY
|
UDI-Device Identifier | 00888912077378 |
UDI-Public | (01)00888912077378 |
Combination Product (y/n) | N |
PMA/PMN Number | K953510 |
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 |
Report Date |
06/13/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/14/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 412-02-046 |
Device Catalogue Number | 412-02-046 |
Device Lot Number | 991B1201 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 06/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/04/2021 |
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 | 425-01-009, LOT 062C1312.; 497-28-000, LOT 629C1678. |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 64 YR |
Patient Sex | Female |
|
|