Brand Name | BLUNTPORT PLUS |
Type of Device | GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
santo domingo 0101 |
DO 0101 |
|
Manufacturer (Section G) |
DAVIS & GECK CARIBE LTD |
zona franca de san isidro |
|
santo domingo 0101 |
DO
0101
|
|
Manufacturer Contact |
sharon
murphy
|
60 middletown avenue |
north haven, CT 06473
|
2034925267
|
|
MDR Report Key | 6566316 |
MDR Text Key | 75108886 |
Report Number | 9612501-2017-05487 |
Device Sequence Number | 1 |
Product Code |
GDH
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K903419 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup,Followup |
Report Date |
05/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/15/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 179775P |
Device Catalogue Number | 179775P |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/24/2017 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/22/2017 |
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 |