Brand Name | ARH SOLUTIONS HEAD 20MM, RIGHT |
Type of Device | PROSTHESIS, ELBOW, HEMI-, RADIAL: HEAD |
Manufacturer (Section D) |
ACUMED LLC |
5885 ne cornelius pass road |
hillsboro, or |
|
MDR Report Key | 10063275 |
MDR Text Key | 191178730 |
Report Number | 3025141-2020-00120 |
Device Sequence Number | 1 |
Product Code |
KWI
|
Combination Product (y/n) | N |
PMA/PMN Number | K131845 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Type of Report
| Initial,Followup |
Report Date |
05/19/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/15/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/15/2023 |
Device Model Number | 5001-0220R-S |
Device Catalogue Number | 5001-0220R-S |
Device Lot Number | 367185 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 05/19/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 41 YR |
Patient Weight | 73 |
|
|