MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1997-08-27 for ONE TOUCH DELUXE HOME ELECTROLYSIS * manufactured by Inverness Corp..
[92062]
Consumer claims she experienced permanent scarring on legs as a result of using the one touch home deluxe electrolysis device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243569-1997-00001 |
| MDR Report Key | 117542 |
| Report Source | 04 |
| Date Received | 1997-08-27 |
| Date of Event | 1996-05-01 |
| Date Mfgr Received | 1997-04-30 |
| Date Added to Maude | 1997-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE TOUCH DELUXE HOME ELECTROLYSIS |
| Generic Name | HOME ELECTROLYSIS UNIT |
| Product Code | HPY |
| Date Received | 1997-08-27 |
| Returned To Mfg | 1996-08-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 86006 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 115275 |
| Manufacturer | INVERNESS CORP. |
| Manufacturer Address | 17-10 WILLOW ST. FAIR LAWN NJ 07410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-27 |