MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-17 for JACOBSON RESONATOR * manufactured by Jacobson Resonance Ent., Inc..
[21589487]
Rptr's child was treated by a dr (retired dentist inactive license in the state of new york). Rptr found out dentist has no license to practice in their state. Rptr was told that the device/resonator created results and should reduce spasticity and this device should help child walk. Child has cerebral palsy from birth. Rptr was told there were no side effects and the device had fda non significant risk (nsr). Rptr later learned that the machine/device had fda nsr on studies of osteoarthritis of the knees - 18 inch machine. Nowhere on any documents did it state nsr for the brain or for the use of the larger device. When rptr questioned this info rptr was dismissed from the clinic and denied treatment. Three days later child experienced seizures for first time ever. Rptr went to the dr and asked dr this question, dr refused to answer, ignored rptr and told rptr they were a troublemaker etc. This dr now claims that clinic is under "irb", engaged in clinical trial studies for neurological disorders. At no point in time was rptr informed that child was in a clinical trial study. No consent form, "irb" clinical trial documentation, length of study, optional treatments etc were ever given to rptr or other parents, or pts. Rptr's question: how can a dr treat and charge in state without a license and say to pts that dr has fda nsr and no side effects. Rptr thinks the "knee" and the brain are different parts of the body. "i may be mistaken". According to rptr this machine can generate heat in parts of the body, headaches, nose bleeds etc. Rptr used to sit in the device holding child or sit next to the machine. Rptr has suffered from major headaches several times a week for the last year.
Patient Sequence No: 1, Text Type: D, B5
[21466458]
Rptr's child was treated by a dr (retired dentist inactive license in the state of new york). Rptr found out dentist has no license to practice in their state. Rptr was told that the device/resonator created results and should reduce spacity and this device should help child walk. Child has cerebral palsy from birth. Rpt was told there were no side effects and the device had fda non significant risk (nsr). Rptr later learned that the machine/device has fda nsr on studies of osteoarthritis of the knees - 18 inch machine. Nowhere on any documents did it state nsr for the brain or for the use of the larger device. When rptr questioned this info rptr was dismissed from the clinic and denied treatment. Three days later child experienced seizures for first time ever. Rptr went to the dr and asked him this question, dr refuses to answer ingored rptr and told rptr they were a trouble maker etc. This dr now claims that clinic is under "irb", engaged in clinical trial studies for neurological disorders. At no point in time was rptr informed that child was in a clinical trial study. No consent form "irb" clinical trial documentation, length of study, optional treatments etc were ever given to rptr or other parents, or pts. Rptr's question: how can a dr treat and charge in state without a license and say to pts that dr has fda nsr and no side effects. Rptr thinks the "knee" and the brain are different parts of the body - "i may be mistaken". Rptr believes what co publishes and what they do in actual treatment are different. According to rptr this machine can generate heat in parts of the body, headaches, nose bleeds etc. Rptr used to sit in the device holding child or sit next to the machine. Rptr has suffered from major headaches several times a week for the last year.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | MW1018943 |
| MDR Report Key | 278764 |
| Date Received | 2000-05-17 |
| Date of Report | 2000-05-17 |
| Date of Event | 1999-03-20 |
| Date Added to Maude | 2000-05-24 |
| 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 | JACOBSON RESONATOR |
| Generic Name | ELECTROMAGNETIC FIELDS DEVICE |
| Product Code | GZI |
| Date Received | 2000-05-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 269778 |
| Manufacturer | JACOBSON RESONANCE ENT., INC. |
| Manufacturer Address | 9960 CENTRAL PARK BLVD #302 BOCA RATON FL 33428 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-17 |
| 2 | 0 | 1. Other | 2000-05-17 |