MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-16 for INTERRO BIOENERGETIC TESTING DEVICE manufactured by Standard Enzyme Co..
[12921]
Consumer called to report a company she had worked for during 1993. The firm conducts "bioenergetic testing" on clients/pts. She stated during phone conversation that user promotes himself as a dr, which is false. She stated that company representatives promise pts results which do not materialize. She states that numerous claims are made concerning co's testing and products.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000573 |
| MDR Report Key | 18267 |
| Date Received | 1994-07-16 |
| Date of Report | 1994-07-16 |
| Date Added to Maude | 1994-12-08 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | INTERRO BIOENERGETIC TESTING DEVICE |
| Product Code | HCC |
| Date Received | 1994-07-16 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18195 |
| Manufacturer | STANDARD ENZYME CO. |
| Manufacturer Address | BREMEN GA 30110 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-07-16 |