Brand Name | ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL |
Type of Device | LARYNGOSCOPE, ENDOSCOPE |
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
|
|
MDR Report Key | 6249650 |
MDR Text Key | 64771191 |
Report Number | 9612501-2017-00100 |
Device Sequence Number | 1 |
Product Code |
GCI
|
UDI-Device Identifier | 10884523000955 |
UDI-Public | (01)10884523000955(17)190430(10)J6D1247MX |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K922123 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/16/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/13/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2019 |
Device Model Number | 173050G |
Device Catalogue Number | 173050G |
Device Lot Number | J6D1247MX |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/16/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |