Brand Name | MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT WITH ENFIT CONNECTORS - 20 FR |
Type of Device | DH EF PEG INITIAL PLACEMENT PRODUCTS |
Manufacturer (Section D) |
AVANOS MEDICAL INC. |
5405 windward parkway |
alpharetta GA 30004 |
|
Manufacturer (Section G) |
AVENT, INC. |
6620 s. memorial place, suite 100 |
|
tucson 85756 |
|
Manufacturer Contact |
lisa
clark
|
5405 windward parkway |
alpharetta, GA 30004
|
4704485444
|
|
MDR Report Key | 10568061 |
MDR Text Key | 207979886 |
Report Number | 3006646024-2020-00032 |
Device Sequence Number | 1 |
Product Code |
KNT
|
UDI-Device Identifier | 00350770446431 |
UDI-Public | 00350770446431 |
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | K924065 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
09/22/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/22/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/31/2021 |
Device Model Number | 9640-20 |
Device Catalogue Number | N/A |
Device Lot Number | 0002995701 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 08/31/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/24/2019 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|