MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-10-16 for ME300 AUTO THERM manufactured by Mettler Electronics Corp..
[971309]
Pt was receiving treatment for low back and hip pain. The pt has diabetes. The pt was wearing slacks during treatment (instruction manual states "clothing covering the area of treatment should be removed so as to be sure metal objects like zippers, tabs, snaps etc. Are not in the field". The treatment area is her right thigh. The pt received a 20-30 min treatment. During treatment, the pt complained of the treatment head getting too hot, the therapist immediately stopped treatment and sent the unit for evaluation. After the treatment, there was no evidence of a burn to the pt. During her next visit, dr. Noticed ulcerations in the treatment area approx the size of a quarter and a dime. The pt did not seek further medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013558-2008-00001 |
| MDR Report Key | 1202684 |
| Report Source | 08 |
| Date Received | 2008-10-16 |
| Date of Report | 2008-10-13 |
| Date of Event | 2008-06-27 |
| Date Mfgr Received | 2008-09-15 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2008-10-28 |
| 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 Contact | ROBERT FLEMING |
| Manufacturer Street | 1333 SOUTH CLAUDINA ST. |
| Manufacturer City | ANAHEIM CA 92805 |
| Manufacturer Country | US |
| Manufacturer Postal | 92805 |
| Manufacturer Phone | 7145332221 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ME300 AUTO THERM |
| Generic Name | DIATHERMY |
| Product Code | IMI |
| Date Received | 2008-10-16 |
| Returned To Mfg | 2008-09-15 |
| Model Number | ME300 |
| Catalog Number | ME300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1251881 |
| Manufacturer | METTLER ELECTRONICS CORP. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-10-16 |