Brand Name | CORE DYNAMICS |
Type of Device | CATHETER, PERITONEAL |
Manufacturer (Section D) |
CONMED CORPORATION |
6455 s yosemite st ste 800 |
greenwood village CO 80111 |
|
MDR Report Key | 13975545 |
MDR Text Key | 288366995 |
Report Number | 13975545 |
Device Sequence Number | 1 |
Product Code |
GBW
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/16/2022 |
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 Model Number | CD8185 |
Device Catalogue Number | CD8185 |
Device Lot Number | 202109205 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/16/2022 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/01/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/01/2022 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/02/2022
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 6205 DA |
Patient Sex | Female |
Patient Weight | 96 KG |
|
|