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 | 9465792 |
MDR Text Key | 196863680 |
Report Number | 9611594-2019-00248 |
Device Sequence Number | 1 |
Product Code |
KGC
|
UDI-Device Identifier | 10680651984323 |
UDI-Public | 10680651984323 |
Combination Product (y/n) | N |
Reporter Country Code | FR |
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 |
12/13/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/13/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/01/2021 |
Device Model Number | 98432 |
Device Catalogue Number | N/A |
Device Lot Number | AA9112R07 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/21/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/29/2019 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 52 YR |
Patient Weight | 52 |