Brand Name | 10FR SILICONE DRAIN WITH TROCAR |
Type of Device | APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED |
Manufacturer (Section D) |
CARDINAL HEALTH 200, LLC |
3651 birchwood dr. |
waukegan IL 60085 |
|
Manufacturer (Section G) |
PR006 PUERTO RICO-ANASCO |
state rd. 402 , north km 0.9 |
|
anasco PR 00610 |
|
Manufacturer Contact |
patricia
tucker
|
3651 birchwood dr. |
waukegan, IL 60085
|
8478874151
|
|
MDR Report Key | 14658546 |
MDR Text Key | 294856688 |
Report Number | 1423537-2022-00784 |
Device Sequence Number | 1 |
Product Code |
GCY
|
UDI-Device Identifier | 10192253022230 |
UDI-Public | 10192253022230 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
06/10/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | SU130-0321 |
Device Catalogue Number | SU130-0321 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
05/17/2022 |
Initial Date FDA Received | 06/10/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 59 YR |
Patient Sex | Male |
Patient Weight | 88 KG |
|
|