Brand Name | GIA PREMIUM |
Type of Device | APPARATUS, SUTURING, STOMACH AND INTESTINAL |
Manufacturer (Section D) |
US SURGICAL PUERTO RICO |
201 sabanetas industrial park |
ponce PR 00716 4401 |
|
Manufacturer (Section G) |
US SURGICAL PUERTO RICO |
201 sabanetas industrial park |
|
ponce PR 00716 4401 |
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 8810333 |
MDR Text Key | 151709792 |
Report Number | 2647580-2019-03767 |
Device Sequence Number | 1 |
Product Code |
FHM
|
UDI-Device Identifier | 20884521031637 |
UDI-Public | 20884521031637 |
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | K801590 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/22/2019 |
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 Expiration Date | 10/31/2023 |
Device Model Number | 030735L |
Device Catalogue Number | 030735L |
Device Lot Number | P8L1191Y |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/04/2019 |
Initial Date FDA Received | 07/22/2019 |
Date Device Manufactured | 11/12/2018 |
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 |