MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-03-22 for ME 300 AUTO THERM ME300 manufactured by Mettler Electronics Corp..
[2576335]
On (b)(6) 2012, i spoke to (b)(6) (lawyer). He alleged that his client, (b)(6), was severly burnt by a mettler me300; shortwave diathermy. The unit was used by clinica medica (b)(6). According to mr. (b)(6), ms. (b)(6) was initially being treated using only hot packs and then was put on the me300 unit - possibly by a non-licensed therapist. Ms. (b)(6) was fully clothed, wearing a thick metal belt, shirt, pants and under garments. Allegedly her clothes caught on fire (mr. (b)(6) has her clothes in his possession), leaving ms. (b)(6) with a burn the size of a grapefruit (which allegedly has already been fixed via cosmetic surgery). Mr. (b)(6) has a lawsuit against the clinic but is not (as of date) implicating mettler nor our me300 device - he alleges clinic misuse/negligence for the cause of the incident.
Patient Sequence No: 1, Text Type: D, B5
[9746405]
Per the me300 user manual - the device is to be used only by a licensed practitioner and pts should not be left unattended for any treatment. In general instruction of the user manual it 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. Contraindications state - "medical diathermy should never be applied over areas which may contain metal, for heat will become concentrated in that area increasing the possibility of tissue damage and deep burns. Clothing containing metal zippers, buckles, snaps, watches, etc. Should be removed prior to treatment. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2013558-2012-00001 |
| MDR Report Key | 2507149 |
| Report Source | 00 |
| Date Received | 2012-03-22 |
| Date of Report | 2012-03-22 |
| Report Date | 2012-03-22 |
| Date Mfgr Received | 2012-03-19 |
| Date Added to Maude | 2012-03-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA CAYUELA, MANAGER |
| Manufacturer Street | 1333 S. 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 | ME 300 AUTO THERM |
| Generic Name | SHORT WAVE DIATHERMY |
| Product Code | IMJ |
| Date Received | 2012-03-22 |
| Model Number | ME300 |
| Catalog Number | ME300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP. |
| Manufacturer Address | 1333 S. CLAUDINA ST ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-22 |