Brand Name | UNKNOWN ESTITCH |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
santo domingo 18750 |
DO 18750 |
|
Manufacturer (Section G) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
|
santo domingo 18750 |
DO
18750
|
|
Manufacturer Contact |
lisa
hernandez
|
60 middletown ave. |
north haven, CT 06473
|
2034925563
|
|
MDR Report Key | 9932557 |
MDR Text Key | 186703307 |
Report Number | 9612501-2020-00615 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/07/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UNKNOWN ESTITCH |
Device Catalogue Number | UNKNOWN ESTITCH |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/24/2020 |
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 Age | 39 YR |