Brand Name | WITOUCH PRO |
Type of Device | TRANSCUTANEOUS ELECTRICAL NERVE SIMULATOR |
Manufacturer (Section D) |
HOLLYWOG, LLC |
100 cherokee boulevard |
suite 123 |
chattanooga TN 37405 |
|
Manufacturer Contact |
michael
treas
|
100 cherokee boulevard |
suite 123 |
chattanooga, TN 37405
|
4233057777
|
|
MDR Report Key | 8795403 |
MDR Text Key | 151200394 |
Report Number | 3008585473-2019-00002 |
Device Sequence Number | 1 |
Product Code |
NUH
|
Combination Product (y/n) | N |
PMA/PMN Number | K171599 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/16/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/16/2019 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 11.1500 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 07/12/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Disability;
|
|
|