Brand Name | REBOUND HRD |
Type of Device | HERNIA EPAIR DEVICE |
Manufacturer (Section D) |
ARB MEDICAL, LLC |
5929 baker road |
suite 470 |
minnetonka MN 55345 |
|
Manufacturer Contact |
|
5929 baker road |
suite 470 |
minnetonka, MN 55345
|
7633547100
|
|
MDR Report Key | 6640527 |
MDR Text Key | 77743463 |
Report Number | 3005770977-2017-00003 |
Device Sequence Number | 1 |
Product Code |
FTL
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
06/13/2017 |
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 |
Physician
|
Device Model Number | RB-SLD-LSO-PP |
Device Lot Number | 150021 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/15/2017 |
Initial Date FDA Received | 06/14/2017 |
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? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|