Brand Name | AW TRANSFER SET FOR BACT ALERT |
Type of Device | TRANSFER SET |
Manufacturer (Section D) |
COVIDIEN |
37 blvd. insurgentes libriamento |
a la p, la mesa |
tijuana |
MX |
|
Manufacturer (Section G) |
COVIDIEN |
37 blvd. insurgentes libriamento |
a la p, la mesa |
tijuana |
MX
|
|
Manufacturer Contact |
edward
almeida
|
15 hampshire st |
mansfield, MA 02048
|
5084524151
|
|
MDR Report Key | 5952471 |
MDR Text Key | 55163751 |
Report Number | 1282497-2016-00687 |
Device Sequence Number | 1 |
Product Code |
LHI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/24/2016 |
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 | 8881225241 |
Device Catalogue Number | 8881225241 |
Device Lot Number | 152820334X |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/24/2016 |
Initial Date FDA Received | 09/15/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/01/2016
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/07/2015 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|