Brand Name | HUDSON SHER-I-BRONCH ACCESSORY PACK |
Type of Device | ENDO BRONCHIAL ACCESSORY PACK |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate, b.c. 2147 8 |
MX
21478
|
|
Manufacturer Contact |
margie
burton, rn
|
3015 carrington mill blvd. |
morrisville, NC 27560
|
9194334965
|
|
MDR Report Key | 4652176 |
MDR Text Key | 5683236 |
Report Number | 3003898360-2015-00222 |
Device Sequence Number | 1 |
Product Code |
BZA
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/13/2015 |
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 |
Other
|
Device Catalogue Number | 5-16142 |
Device Lot Number | 73J1400258 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/25/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/13/2015
|
Initial Date FDA Received | 04/01/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|