Brand Name | INTRODUCER KIT FOR JEJUNAL/GASTRIC FEEDING TUBE, 20FR DILATOR |
Type of Device | DH EF PERC PLACEMENT PRODUCTS |
Manufacturer (Section D) |
AVANOS MEDICAL INC. |
5405 windward parkway |
alpharetta GA 30004 |
|
Manufacturer (Section G) |
AVENT SA DE R.L. DE C.V. (AVENT 1) |
circuito industial no.40 |
colonia obrera |
nogales, cp 84048 |
MX
84048
|
|
Manufacturer Contact |
lisa
clark
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485444
|
|
MDR Report Key | 10537499 |
MDR Text Key | 207337259 |
Report Number | 9611594-2020-00171 |
Device Sequence Number | 1 |
Product Code |
KGC
|
UDI-Device Identifier | 00350770984377 |
UDI-Public | 00350770984377 |
Combination Product (y/n) | N |
Reporter Country Code | DA |
PMA/PMN Number | K080253 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,other |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/15/2020 |
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 |
Health Professional
|
Device Model Number | 98437 |
Device Catalogue Number | N/A |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/25/2020 |
Initial Date FDA Received | 09/15/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |