Brand Name | HIP KIT |
Type of Device | DISPOSABLE SURGICAL IRRIGATION/ASPIRATION SYSTEM |
Manufacturer (Section D) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
dover OH 44622 |
|
Manufacturer (Section G) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
|
dover OH 44622 |
|
Manufacturer Contact |
jennifer
rapsavage
|
56 e. bell drive |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 18324067 |
MDR Text Key | 330478420 |
Report Number | 0001526350-2023-01640 |
Device Sequence Number | 1 |
Product Code |
FQH
|
UDI-Device Identifier | 00889024375192 |
UDI-Public | (01)00889024375192(17)260427(10)70211939 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/14/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/14/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00515048201 |
Device Lot Number | 70211939 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/11/2023 |
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
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |
Patient Sex | Prefer Not To Disclose |