MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-30 for ALOE SOUND LOTION manufactured by Rich-mar Corp..
[170997]
Due to an accident, the complainant was receiving dr prescribed ultrasound therapy 3 times a week. During the first week pt experienced an itching on their back, and at the second week pt broke out in a rash that resulted in some bleeding. Visited dr and was prescribed medication. The diagnosis was contact dermatitis. Pt called ultrasound therapist to inform them that they could no longer continue therapy because of the lotion, and the therapist told pt that three others had just informed them that they also had a similar reaction. The complainant called rich-mar corp and was told that they do not manufacture the product, and did not know if the formulation had been changed. Web search at www. Richmarweb. Com/access. Html found the product with the ad. "aloe based ultrasound coupling lotion. Designed for ultrasound, but also great for massage. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002782 |
| MDR Report Key | 279612 |
| Date Received | 2000-05-30 |
| Date of Report | 2000-05-30 |
| Date Added to Maude | 2000-05-31 |
| 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 |
| 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 | ALOE SOUND LOTION |
| Generic Name | ULTRASOUND LOTION |
| Product Code | MUI |
| Date Received | 2000-05-30 |
| Model Number | NA |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270602 |
| Manufacturer | RICH-MAR CORP. |
| Manufacturer Address | 15499 E. 590TH RD. PO BOX 879 INOLA OK 74036 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-05-30 |