Brand Name | EEA 28MM SINGLE-USE STAPLER |
Type of Device | STAPLER, SURGICAL |
Manufacturer (Section D) |
COVIDIEN, FORMERLY USSC PUERTO RICO INC |
building 911-67 |
sabanetas industrial park |
ponce PR 00731 |
|
Manufacturer (Section G) |
COVIDIEN, FORMERLY USSC PUERTO RICO INC |
building 911-67 |
sabanetas industrial park |
ponce PR 00731 |
|
Manufacturer Contact |
sharon
murphy
|
60 middletown ave |
north haven, CT 06473
|
|
MDR Report Key | 6339294 |
MDR Text Key | 67697379 |
Report Number | 2647580-2017-00160 |
Device Sequence Number | 1 |
Product Code |
GAG
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K062850 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
01/21/2017 |
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 Expiration Date | 10/31/2021 |
Device Model Number | EEA28 |
Device Catalogue Number | EEA28 |
Device Lot Number | P6K0306KX |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/21/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/21/2017 |
Initial Date FDA Received | 02/17/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/12/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/01/2016 |
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 |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|