MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-25 for THERAGUN G3PRO manufactured by Theragun, Llc.
[143422807]
I used the theragun g3pro device which seems to be a medical device at least other similar devices of the mfr are listed in the database. Using the device felt really painful and i found the user manual did not provide sufficient info when or how to use the device correctly. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086210 |
| MDR Report Key | 8555742 |
| Date Received | 2019-04-25 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-04-05 |
| Date Added to Maude | 2019-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THERAGUN G3PRO |
| Generic Name | MASSAGER, THERAPEUTIC, ELECTRIC |
| Product Code | ISA |
| Date Received | 2019-04-25 |
| Model Number | G3PRO |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THERAGUN, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-25 |