Brand Name | TIS RET SYS 10MM, 180ML(5/BX) |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
CONSOLIDATED MEDICAL EQUIPMENT |
alejandro dumas ave, 11321 |
complejo industrial chihuahua |
chihuahua, 31136 |
MX 31136 |
|
Manufacturer (Section G) |
CONSOLIDATED MEDICAL EQUIPMENT |
alejandro dumas ave, 11321 |
complejo industrial chihuahua |
chihuahua, 31136 |
MX
31136
|
|
Manufacturer Contact |
john
berga
|
11311 concept blvd. |
largo, fl
|
3995358
|
|
MDR Report Key | 9728106 |
MDR Text Key | 206388343 |
Report Number | 3007305485-2020-00048 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 20653405986109 |
UDI-Public | (01)20653405986109(17)221113(10)201911144 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172940 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/19/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/19/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/13/2022 |
Device Model Number | TRS100SB2 |
Device Catalogue Number | TRS100SB2 |
Device Lot Number | 201911144 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/28/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/14/2019 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |