MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-03 for FLUIDTHERAPY UNKNOWN manufactured by Henley Intl..
[8113]
Use of this device involves putting an arm or leg in a field of ground corn husks, heated, with air blown to creat a "fluid" movement of the corn particles. The media, (corn husks), is constantly reused from one pt to the next, and bare skin comes in contact with this media. Open wounds can be just covered with a bandage. A detailed microbiological study showed very small concentrations of benign bacteria similar to those found in the air. The mechanism by which the device maintains continuous sterility has not been unequivocally established. Study does not mention testing for viral transmission. Rptr questions if this is a regulated medical device and does it have to pass some kind of standard to prove it is safe, from blood-borne pathogens perspective. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000628 |
| MDR Report Key | 11268 |
| Date Received | 1994-02-03 |
| Date of Report | 1994-02-01 |
| Date Added to Maude | 1994-02-04 |
| 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 |
| 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 | FLUIDTHERAPY |
| Product Code | LSB |
| Date Received | 1994-02-03 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11268 |
| Manufacturer | HENLEY INTL. |
| Manufacturer Address | SUGAR LAND TX 77478 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-02-03 |