Brand Name | TENOTAC SOFT TISSUE FIXATION SYSTEM |
Type of Device | STERILE-FEMALE IMPLANT, SHORT |
Manufacturer (Section D) |
PARAGON 28, INC. |
14445 grasslands dr. |
englewood CO 80112 |
|
Manufacturer Contact |
victoria
akinboboye
|
14445 grasslands dr. |
englewood, CO 80112
|
7207165439
|
|
MDR Report Key | 16419194 |
MDR Text Key | 309993091 |
Report Number | 3008650117-2023-00045 |
Device Sequence Number | 1 |
Product Code |
HWC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/22/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/22/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | P42-322-0065-S |
Device Catalogue Number | P42-322-0065-S |
Device Lot Number | PA2021004896 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 01/12/2023 |
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;
|