MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-08-06 for IONTOPHORESIS GROUNDER PATCH manufactured by Life Tech, Inc..
[20982]
A new type of iontophoresis grounder patch was set up using 1cc of dexamethasone,. 25cc epinephrine, and 1cc lidocaine in the electrodes used to transfer the medications. A new trial pad was placed on the pt's upper arm and the "+" charge started. Pt tolerated current 4. 00 when the "-" dose was started and reached. 51. Pt complained it was burning her arm. Treatment immediately stopped. Pt received first degree burn where patch was attached. Affected area iced - examined in er. Symptoms gone by the end of day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 37100 |
| MDR Report Key | 37100 |
| Date Received | 1996-08-06 |
| Date of Report | 1996-03-11 |
| Date of Event | 1996-03-03 |
| Date Facility Aware | 1996-03-03 |
| Report Date | 1996-03-11 |
| Date Reported to Mfgr | 1996-03-13 |
| Date Added to Maude | 1996-09-12 |
| 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 | OCCUPATIONAL THERAPIST |
| 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 GROUNDER PATCH |
| Generic Name | IONTOPHORESIS GROUNDER PATCH |
| Product Code | KTB |
| Date Received | 1996-08-06 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 38466 |
| Manufacturer | LIFE TECH, INC. |
| Manufacturer Address | 10920 KINGHURST DR HOUSTON TX 77099 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-08-06 |