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..
[19626]
Pt received small circular burn as a result of the iontophoreic treatment. The burn has caused secondary to the electrode contact with the skin.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 29865 |
MDR Report Key | 29865 |
Date Received | 1996-01-16 |
Date of Report | 1996-01-12 |
Date of Event | 1995-12-01 |
Date Facility Aware | 1995-12-01 |
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 | IONTOPHERESIS 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 | 1.5 YR |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 30946 |
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 |