Brand Name | BULK SURG PAT 1/2 X 1/2 |
Type of Device | PADDIE, COTTONOID |
Manufacturer (Section D) |
CODMAN & SHURTLEFF, INC. |
325 paramount drive |
raynham MA 02767 |
|
Manufacturer (Section G) |
CODMAN & SHURTLEFF, INC. |
325 paramount drive |
|
raynham MA 02767 |
|
Manufacturer Contact |
karen
anigbo
|
11 cabot boulevard |
mansfield, MA 02048
|
7819715608
|
|
MDR Report Key | 8159867 |
MDR Text Key | 131380595 |
Report Number | 1226348-2018-10880 |
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 |
distributor |
Reporter Occupation |
|
Type of Report
| Initial,Followup,Followup |
Report Date |
12/05/2018 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 12/13/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Catalogue Number | 24-5404 |
Device Lot Number | HX7561 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 01/21/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 06/28/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
|
|