Brand Name | ARH SLIDE-LOC¿ NECK +1MM |
Type of Device | PROSTHESIS, ELBOW, HEMI-, RADIAL, NECK |
Manufacturer (Section D) |
ACUMED LLC |
5885 nw cornelius pass road |
hillsboro OR 97124 9432 |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 nw cornelius pass road |
|
hillsboro OR 97124 9432 |
|
Manufacturer Contact |
micki
lehman
|
5885 nw cornelius pass road |
hillsboro, OR 97124-9432
|
8886279957
|
|
MDR Report Key | 7003962 |
MDR Text Key | 91120178 |
Report Number | 3025141-2017-00270 |
Device Sequence Number | 1 |
Product Code |
KWI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K131845 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/23/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/06/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Physician
|
Device Expiration Date | 02/14/2023 |
Device Model Number | 5001-0301N-S |
Device Catalogue Number | 5001-0301N-S |
Device Lot Number | 374638 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/25/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 10/23/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/18/2016 |
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;
|
Patient Age | 47 YR |
Patient Weight | 75 |
|
|