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..
[16787709]
Pt received iontophoresis treatment utilizing new electrode. Procedure followed according to mfrs instructions. Iontophoresis protocal followed for 1. 5 ma. Pt reported no burning during treatment and skin inspection was negative. The next day pt reported 2 small 3-4 mm blisters on anterior rt shoulder.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1012436 |
MDR Report Key | 130576 |
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 | 127697 |
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 |