Brand Name | CHROMIC GUT SIZE 7-0 USP (0.7 METRIC), 18 INCHES ( |
Type of Device | SURGICAL ABSORBABLE GUT SUTURE |
Manufacturer (Section D) |
COVIDIEN |
zona franca de san isidro |
carretara san isidro km17 |
santo domingo |
DR |
|
Manufacturer (Section G) |
COVIDIEN |
zona franca de san isidro |
carretara san isidro km17 |
santo domingo |
DR
|
|
Manufacturer Contact |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 4904540 |
MDR Text Key | 17205140 |
Report Number | 9612501-2015-00393 |
Device Sequence Number | 1 |
Product Code |
GAL
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K885018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/10/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | G2797K |
Device Catalogue Number | G2797K |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
06/10/2015
|
Initial Date FDA Received | 07/09/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|