Brand Name | INTRODUCER KIT FOR GASTROSTOMY 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 | 9712676 |
MDR Text Key | 199135366 |
Report Number | 9611594-2020-00027 |
Device Sequence Number | 1 |
Product Code |
KGC
|
UDI-Device Identifier | 10680651984323 |
UDI-Public | 10680651984323 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K080253 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/14/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/14/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/01/2020 |
Device Model Number | 98432 |
Device Catalogue Number | N/A |
Device Lot Number | AA8316R07 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/30/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/13/2018 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 2 YR |
Patient Weight | 12 |