Brand Name | SURGUARD2 SAFETY NEEDLE |
Type of Device | TERUMO NEOLUS NEEDLE |
Manufacturer (Section D) |
TERUMO PHILIPPINES CORPORATION |
124 east main avenue |
laguna technopark |
binan, laguna |
RP |
|
Manufacturer (Section G) |
TERUMO PHILIPPINES CORPORATION |
124 east main avenue |
laguna technopark |
binan, laguna |
RP
|
|
Manufacturer Contact |
cathleen
hargreaves
|
950 elkton blvd. |
elkton, MD 21921
|
8002837866
|
|
MDR Report Key | 4214868 |
MDR Text Key | 5040036 |
Report Number | 3003902955-2014-00021 |
Device Sequence Number | 1 |
Product Code |
MEG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | E270462 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/02/2014,10/30/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/30/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2019 |
Device Catalogue Number | 102-N251S |
Device Lot Number | 140721B |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 09/30/2014 |
Device Age | 2 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/02/2014 |
Date Manufacturer Received | 11/10/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/21/2014 |
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 |
Treatment | SYRINGE |
|
|