Brand Name | HUDSON CIRCUIT,NEONATAL,DUAL HTD LIMB W/DUAL W |
Type of Device | BREATHING CIRCUIT |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 88275 |
MX
88275
|
|
Manufacturer Contact |
margie
burton, rn
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334965
|
|
MDR Report Key | 5021149 |
MDR Text Key | 23703975 |
Report Number | 3004365956-2015-00273 |
Device Sequence Number | 1 |
Product Code |
CAG
|
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 |
Respiratory Therapist
|
Report Date |
08/11/2015 |
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 |
No Information
|
Device Catalogue Number | 780-15 |
Device Lot Number | 74C1500347 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 08/21/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/02/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|