MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-07-26 for EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROID 200001 manufactured by Eclosion Kft.
[678587]
Health professional was using the device on herself. She used the device incorrectly in that she placed the harness lead connectors against her skin. She had an allergic reaction which caused inflammation that led to skin urticaria.
Patient Sequence No: 1, Text Type: D, B5
[7807637]
This insignificant risk of skin irritation is due to inappropriate use of the harnesses. This further prompted us to change the labeling to show a clear warning. The labeling has been changed to warn users not to place the harness connectors against the skin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004444071-2007-00001 |
| MDR Report Key | 886687 |
| Report Source | 08 |
| Date Received | 2007-07-26 |
| Date of Report | 2007-07-23 |
| Date of Event | 2007-05-09 |
| Date Mfgr Received | 2007-05-21 |
| Device Manufacturer Date | 2007-03-26 |
| Date Added to Maude | 2007-09-18 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | KALVARIA TER 2 |
| Manufacturer City | BUDAPEST H-1089 |
| Manufacturer Country | HU |
| Manufacturer Postal | H-1089 |
| Manufacturer Phone | 3036043 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPFX ELECTRO PHYSIOLOGICAL FEEDBACK XRROID |
| Generic Name | BIOFEEDBACK DEVICE |
| Product Code | HCC |
| Date Received | 2007-07-26 |
| Catalog Number | 200001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 869620 |
| Manufacturer | ECLOSION KFT |
| Manufacturer Address | KALVARIA TER 2 BUDAPEST HU H-1089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-26 |