Brand Name | BIPOLAR HEAD ASSEMBLY TOOL |
Type of Device | HIP INSTRUMENTS : MISC |
Manufacturer (Section D) |
DEPUY INTERNATIONAL LTD - 8010379 |
st. anthony's road |
leeds LS11 8DT |
UK
LS11 8DT |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic dr |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380
|
6107428552
|
|
MDR Report Key | 8581937 |
MDR Text Key | 144262706 |
Report Number | 1818910-2019-92526 |
Device Sequence Number | 1 |
Product Code |
KWA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup |
Report Date |
04/13/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 05/06/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | 855762000 |
Device Lot Number | SM6154809 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/24/2019 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 07/01/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/15/2005 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unkown
|