Brand Name | ARC WRIST TOWER TRAY 1 OF 2 |
Type of Device | APPARATUS, TRACTION, NON-POWERED |
Manufacturer (Section D) |
ACUMED, LLC |
5885 ne cornelius pass road |
hillsboro OR 97124 |
|
Manufacturer (Section G) |
ACUMED LLC |
5885 ne cornelius pass road |
|
hillsboro OR 97124 |
|
Manufacturer Contact |
ellie
wood
|
5885 ne cornelius pass road |
hillsboro, OR 97124
|
5035209618
|
|
MDR Report Key | 14246038 |
MDR Text Key | 294666225 |
Report Number | 3025141-2022-00118 |
Device Sequence Number | 1 |
Product Code |
HST
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
08/03/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/28/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 10100001 |
Device Catalogue Number | 10100001 |
Device Lot Number | 523151 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Manufacturer Received | 08/03/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |