Brand Name | CADD® CADD-LEGACY® DUODOPA PUMP |
Type of Device | PUMP, INFUSION, ENTERAL |
Manufacturer (Section D) |
SMITHS MEDICAL, ASD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
MDR Report Key | 7786280 |
MDR Text Key | 117270740 |
Report Number | 3012307300-2018-03290 |
Device Sequence Number | 1 |
Product Code |
LZH
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,distributor,foreign |
Type of Report
| Initial,Followup |
Report Date |
10/23/2018 |
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 |
Lay User/Patient
|
Device Catalogue Number | 21-1400-08 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/31/2018 |
Initial Date Manufacturer Received |
07/17/2018 |
Initial Date FDA Received | 08/15/2018 |
Supplement Dates Manufacturer Received | 09/26/2018
|
Supplement Dates FDA Received | 10/23/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | CARBIDOPA; LEVODOPA |
|
|