Brand Name | SALEM SUMP |
Type of Device | TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION |
Manufacturer (Section D) |
COVIDIEN LP |
710 medtronic parkway |
minneapolis MN 55432 5604 |
|
MDR Report Key | 7333618 |
MDR Text Key | 102249317 |
Report Number | 7333618 |
Device Sequence Number | 1 |
Product Code |
FEG
|
UDI-Device Identifier | 10884521004726 |
UDI-Public | (01)10884521004726 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial,Followup |
Report Date |
03/09/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 8888266148 |
Device Catalogue Number | 8888266148 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/09/2018 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/09/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/13/2018 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/13/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|