Brand Name | ENDOVIVE GASTROSTOMY TUBE WITH ENFIT CONNECTOR |
Type of Device | GASTROSTOMY TUBE |
Manufacturer (Section D) |
XERIDIEM MEDICAL DEVICES |
4700 s. overland drive |
tucson AZ 85714 3430 |
|
Manufacturer (Section G) |
XERIDIEM MEDICAL DEVICES |
4700 s. overland drive |
|
tucson AZ 85714 3430 |
|
Manufacturer Contact |
steve
murray
|
4700 s. overland drive |
tucson, AZ 85714-3430
|
5208827794
|
|
MDR Report Key | 18332720 |
MDR Text Key | 330551424 |
Report Number | 2025851-2023-00009 |
Device Sequence Number | 1 |
Product Code |
PIF
|
UDI-Device Identifier | 813939023619 |
UDI-Public | (01)813939023619(17)230524(10)1065604 |
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K171347 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/14/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/14/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/24/2023 |
Device Model Number | 70-0051-218 |
Device Catalogue Number | M00509911 |
Device Lot Number | 10656-04 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/15/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/24/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 94 YR |