Brand Name | UNK DURASEAL PRODUCT |
Type of Device | DURASEAL SEALANT |
Manufacturer (Section D) |
COVIDIEN, FORMERLY US |
60 middletown avenue |
north haven CT 06473 |
|
Manufacturer (Section G) |
COVIDIEN LP, FORMERLY US SURGICAL A |
60 middletown avenue |
|
north haven CT 06473 |
|
Manufacturer Contact |
sharon
murphy, qa
|
60 middletown avenue |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 3850702 |
MDR Text Key | 4412578 |
Report Number | 1219930-2014-00212 |
Device Sequence Number | 1 |
Product Code |
NQR
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P040034 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Literature,Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
02/19/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK DURASEAL |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/19/2014 |
Initial Date FDA Received | 03/19/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|