Brand Name | 30 SILICONE PIP IMPLANT (STERILE PACKED) |
Type of Device | PROSTHESIS, FINGER, CONSTRAINED, POLYMER |
Manufacturer (Section D) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ 2545 |
|
Manufacturer (Section G) |
STRYKER GMBH |
bohnackerweg 1 |
postfach |
selzach 2545 |
SZ
2545
|
|
Manufacturer Contact |
sharon
rivas
|
325 corporate drive |
mahwah, NJ 07430
|
2018315000
|
|
MDR Report Key | 12793183 |
MDR Text Key | 280887919 |
Report Number | 0008031020-2021-00455 |
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 | K931588 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/11/2021 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | PIP-30 |
Device Catalogue Number | PIP30 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/14/2021
|
Initial Date FDA Received | 11/11/2021 |
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;
Hospitalization;
|
Patient Age | 58 YR |
Patient Sex | Female |
Patient Weight | 66 KG |