MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-01-16 for PHORESOR II PM 700 manufactured by Iomed, Inc..
[16356]
Pt received small circular burn as a result of the iontophoreic treatment. The burn was caused secondary to the electrode contract with the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 29864 |
| MDR Report Key | 29864 |
| Date Received | 1996-01-16 |
| Date of Report | 1996-01-12 |
| Date of Event | 1995-12-06 |
| Date Facility Aware | 1995-12-06 |
| Report Date | 1996-01-12 |
| Date Reported to Mfgr | 1995-12-15 |
| Date Added to Maude | 1996-02-12 |
| 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 | PHORESOR II |
| Generic Name | IONTOPHORESIS DEVICE |
| Product Code | KTB |
| Date Received | 1996-01-16 |
| Returned To Mfg | 1995-12-27 |
| Model Number | PM 700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 18 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30945 |
| Manufacturer | IOMED, INC. |
| Manufacturer Address | 1290 W 2320 SOUTH SALT LAKE CITY UT 84119 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-01-16 |