Brand Name | BARD PARKER |
Type of Device | BLADE SURG RIB BCK CARB 15 BLADE |
Manufacturer (Section D) |
ASPEN SURGICAL |
6945 southbelt dr. s.e. |
caledonia MI 49316 |
|
Manufacturer (Section G) |
ROI CPS, LLC |
3000 east sawyer road |
|
republic MO 65738 |
|
Manufacturer Contact |
cheyenne
stewart
|
3000 east sawyer road |
republic, MO 65738
|
4176473205
|
|
MDR Report Key | 13334456 |
MDR Text Key | 294402912 |
Report Number | 3014527682-2022-00001 |
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 |
Health Professional,User Facility |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/24/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 371115 |
Device Catalogue Number | 371115 |
Device Lot Number | 260152 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/04/2022 |
Initial Date FDA Received | 01/24/2022 |
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 |