MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for IONTO PATCH STAT manufactured by Travanti Medical / Tapemark Co..
[139111212]
Pt being treated for left lateral epicondylitis: the path had exposed metal. This caused a burn, slightly smaller than a dime. Upon examination, wound had scabbed over and no signs of infection. Pt reports no pain. Location where event occurred: outpatient treatment facility - physical therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084930 |
| MDR Report Key | 8424840 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-03-06 |
| Date Added to Maude | 2019-03-15 |
| 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 |
| 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 | IONTO PATCH STAT |
| Generic Name | DEVICE, IONTOPHORESIS, OTHER USES |
| Product Code | EGJ |
| Date Received | 2019-03-13 |
| Lot Number | 7011-4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRAVANTI MEDICAL / TAPEMARK CO. |
| Brand Name | IONTO PATCH STAT |
| Generic Name | DEVICE, IONTOPHORESIS, OTHER USES |
| Product Code | EGJ |
| Date Received | 2019-03-13 |
| Lot Number | 7011-4 S-10 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TRAVANTI MEDICAL / TAPEMARK CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-13 |