MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-13 for HENLEY HEALTHCARE * manufactured by Henley Healthcare.
[38096]
Pt receiving iontophoresis treatment to wrist, sustained 2 small burns.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 56883 |
MDR Report Key | 56883 |
Date Received | 1996-12-13 |
Date of Report | 1996-12-10 |
Report Date | 1996-12-10 |
Date Added to Maude | 1996-12-20 |
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 |
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 | HENLEY HEALTHCARE |
Generic Name | * |
Product Code | KTB |
Date Received | 1996-12-13 |
Model Number | * |
Catalog Number | * |
Lot Number | HWC |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | UNKNOWN |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 57399 |
Manufacturer | HENLEY HEALTHCARE |
Manufacturer Address | 120 INDUSTRIAL BLVD SURGARLAND TX 77478 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1996-12-13 |