Brand Name | PIP SZ. 30 PROXIMAL |
Type of Device | PIP |
Manufacturer (Section D) |
ASCENSION ORTHOPEDICS, INC. |
austin TX 78754 |
|
Manufacturer Contact |
caren
finkelstein
|
315 enterprise dr. |
plainsboro, NJ 08536
|
6099362341
|
|
MDR Report Key | 3708438 |
MDR Text Key | 20781609 |
Report Number | 1651501-2014-00016 |
Device Sequence Number | 1 |
Product Code |
MPK
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | H010005 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/25/2014 |
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 |
Health Professional
|
Device Catalogue Number | PIP-200-30P-WW |
Device Lot Number | 13-0636 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
02/25/2014 |
Initial Date FDA Received | 03/14/2014 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|