Brand Name | ATTUNE FEMORAL INTRODUCER |
Type of Device | ATTUNE INSTRUMENTS : INSERTION DEVICES |
Manufacturer (Section D) |
DEPUY IRELAND 9616671 |
loughbeg, ringaskiddy co. |
cork |
EI |
|
Manufacturer (Section G) |
DEPUY ORTHOPAEDICS, INC. 1818910 |
700 orthopaedic drive |
|
warsaw IN 46582 0988 |
|
Manufacturer Contact |
kara
ditty-bovard
|
1210 ward avenue |
west chester, PA 19380
|
6103142063
|
|
MDR Report Key | 8286021 |
MDR Text Key | 134372974 |
Report Number | 1818910-2019-82681 |
Device Sequence Number | 1 |
Product Code |
HWR
|
UDI-Device Identifier | 10603295130215 |
UDI-Public | 10603295130215 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/09/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 254401005 |
Device Lot Number | ABB47842 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/23/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/09/2019 |
Initial Date FDA Received | 01/29/2019 |
Supplement Dates Manufacturer Received | 02/04/2019
|
Supplement Dates FDA Received | 02/05/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/23/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |