MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-13 for IOTRODE PAD * manufactured by Henley Div..
[39078]
Pt received iontophoresis treatment to bilateral anterior shoulders, 2 small burns were noted one over each anterior shoulder at location of electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 56880 |
| MDR Report Key | 56880 |
| Date Received | 1996-12-13 |
| Date of Report | 1996-06-10 |
| Date of Event | 1996-06-03 |
| Report Date | 1996-12-10 |
| Date Added to Maude | 1996-12-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOTRODE PAD |
| Generic Name | IOTRODE ELECTRODE |
| Product Code | KTB |
| Date Received | 1996-12-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | HWC |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 57396 |
| Manufacturer | HENLEY DIV. |
| Manufacturer Address | 120 INDUSTRIAL BLVD SUGARLAND TX 77478 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-13 |