Brand Name | BULK SURG STRIP 1/4 X 6 |
Type of Device | PADDIE, COTTONOID |
Manufacturer (Section D) |
CODMAN & SHURTLEFF, INC. |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer Contact |
james
kenney
|
325 paramount drive |
raynham, MA 02767
|
5088282726
|
|
MDR Report Key | 6095673 |
MDR Text Key | 59717360 |
Report Number | 1226348-2016-10783 |
Device Sequence Number | 1 |
Product Code |
HBA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K880402 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 24-5431 |
Device Lot Number | C58961, 751552 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/07/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
10/24/2016 |
Initial Date FDA Received | 11/11/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/15/2016
|
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 |
Patient Outcome(s) |
Required Intervention;
|
|
|