Brand Name | ENDO UNIVERSAL 65 |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
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 | 9263893 |
MDR Text Key | 164575534 |
Report Number | 2647580-2019-05442 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 10884521070523 |
UDI-Public | 10884521070523 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K912097 |
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,Followup |
Report Date |
12/10/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/31/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 02/29/2024 |
Device Model Number | 173052 |
Device Catalogue Number | 173052 |
Device Lot Number | P9C1511Y |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/01/2019 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/22/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/20/2019 |
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 |