Brand Name | 30 SILICONE PIP IMPLANT (STERILE PACKED) |
Type of Device | PROSTHESIS, FINGER, CONSTRAINED, POLYMER |
Manufacturer (Section D) |
ENCORE MEDICAL L.P |
9800 metric blvd |
austin TX 78758 |
|
Manufacturer (Section G) |
ENCORE MEDICAL L.P |
9800 metric blvd |
|
austin TX 78758 |
|
Manufacturer Contact |
james
mcmahon
|
9800 metric blvd |
austin, TX 78758
|
|
MDR Report Key | 16773679 |
MDR Text Key | 313628147 |
Report Number | 1644408-2023-00462 |
Device Sequence Number | 1 |
Product Code |
KYJ
|
UDI-Device Identifier | 00886385021553 |
UDI-Public | 00886385021553 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | UNKNOWN |
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 |
Report Date |
04/27/2023 |
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 Model Number | PIP-30 |
Device Catalogue Number | PIP-30 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
03/29/2023
|
Initial Date FDA Received | 04/19/2023 |
Supplement Dates Manufacturer Received | 04/26/2023
|
Supplement Dates FDA Received | 04/27/2023
|
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 Number | 1 |
Patient Outcome(s) |
Required Intervention;
|