Brand Name | BARD-PARKER |
Type of Device | STAINLESS STEEL BLADES SIZE 15, STERILE |
Manufacturer (Section D) |
ASPEN SURGICAL PRODUCTS, INC. |
caledonia MI |
|
Manufacturer Contact |
|
6945 southbelt dr. s.e. |
caledonia, MI 49316
|
6166987100
|
|
MDR Report Key | 4196966 |
MDR Text Key | 5038091 |
Report Number | 1836161-2014-00060 |
Device Sequence Number | 1 |
Product Code |
GES
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/07/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/13/2014 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 371215 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/25/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|