MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-06 for IONTOPHORETIC DRUG DELIVERY SYSTEM PHORESOR II PM700 manufactured by Iomed, Inc..
[16755972]
Pt experienced an electrical burn on right forearm while using equipment included in her occupational therapy program. Electrode @1 was placed on right hand/radial thumb area, electrode #2 placed on dorsal right wrist. Timer: 2 minutes. Output: 2 milliamps burn on electrode #2, dorsal forearm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17601 |
| MDR Report Key | 17601 |
| Date Received | 1994-10-06 |
| Date of Report | 1994-10-05 |
| Date of Event | 1994-05-19 |
| Date Facility Aware | 1994-05-19 |
| Report Date | 1994-10-05 |
| Date Reported to FDA | 1994-10-05 |
| Date Reported to Mfgr | 1994-10-05 |
| Date Added to Maude | 1994-11-14 |
| 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 | IONTOPHORETIC DRUG DELIVERY SYSTEM |
| Product Code | KTB |
| Date Received | 1994-10-06 |
| Model Number | PHORESOR II PM700 |
| Lot Number | 14498 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17519 |
| Manufacturer | IOMED, INC. |
| Manufacturer Address | SALT LAKE CITY UT 841199907 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-06 |