MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-29 for IONTOPHORESIS UNIT PM700 manufactured by Iomed, Inc..
[21112]
During physical therapy the pt sustained a small burn on the dorsum of the right foot with the use of the dispersive pad on the machine. Silvadene applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29614 |
| MDR Report Key | 29614 |
| Date Received | 1995-12-29 |
| Date of Report | 1995-11-27 |
| Date of Event | 1995-06-08 |
| Date Facility Aware | 1995-06-08 |
| Report Date | 1995-11-27 |
| Date Reported to FDA | 1995-11-29 |
| Date Reported to Mfgr | 1995-11-29 |
| Date Added to Maude | 1996-02-06 |
| 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 | IONTOPHORESIS UNIT |
| Generic Name | IONTOPHORESIS UNIT |
| Product Code | KTB |
| Date Received | 1995-12-29 |
| Model Number | PM700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30703 |
| Manufacturer | IOMED, INC. |
| Manufacturer Address | 12960 WEST 2320 SOUTH SUITE A SALT LAKE CITY UT 841191476 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-12-29 |