MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-06 for MEDITRODE 6570M * manufactured by Life Tech International, Inc.
[113721]
Pt received iontophoresis treatment utilizing new electrode. Procedure followed according to mfrs instructions. Iontophoresis protocal followed for 1-5 miliamps. Pt reported no burning during treatment. At end of treatment it was noted that pt had 3 small (1 1/2 mm) blistered areas.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012435 |
| MDR Report Key | 130569 |
| Date Received | 1997-11-06 |
| Date of Report | 1997-10-17 |
| Date of Event | 1997-10-08 |
| Date Added to Maude | 1997-11-12 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHYSICAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDITRODE |
| Generic Name | DRUG DELIVERY ELECTRODE |
| Product Code | KTB |
| Date Received | 1997-11-06 |
| Model Number | 6570M |
| Catalog Number | * |
| Lot Number | 3708503 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 127690 |
| Manufacturer | LIFE TECH INTERNATIONAL, INC |
| Manufacturer Address | 10920 KINGHURST HOUSTON TX 77099 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-11-06 |