MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-08-03 for AUTO*THERM SHORTWAVE DIATHERMY ME 300 manufactured by Mettler Electronics Corp..
[22389379]
The autotherm 300, model me300, shortwave diathermy is a pre-amendment (<1976) device that is no longer being produced.
Patient Sequence No: 1, Text Type: N, H10
[22389380]
On (b)(6) 2015, (b)(6) (marketing manager) received a phone call from dr. (b)(6) (chiropractor in (b)(6)). He stated that in april he treated a patient on the back of the calf to relieve muscle cramping in the calf. Patient had jeans on during the treatment. He reported burning feeling during the treatment. The doctor rubbed on the area to dissipate sweat in the area and resumed the treatment. No additional discomfort was reported by the patient. The patient has diabetes and is a male, approximately (b)(6). He exercises regularly and is in generally good health, all according to the doctor. After returning home to (b)(6), the patient called and reported a penny size burn on the back of the calf. He had sought medical attention and has had intervention by a wound care specialist. The wound is now a dime size and is still not completely healed, as noted by the doctor during phone conversation. Dr. (b)(6) stated that he always treats patients over their clothing and has never had a problem. He does take care to make sure there is no metal in the treatment area. An le (manufacturer's quality systems associate) called dr. (b)(6) back on (b)(6) 2015 to get more information. He refused to send the device back to manufacturer's facility for evaluation. He also mentioned that he already tested the device on himself and no problem was found. So he decided to continue using the device for other patients and no complaint was made so far.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013558-2015-00001 |
| MDR Report Key | 4977081 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-04-01 |
| Date Mfgr Received | 2015-07-27 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2015-08-06 |
| 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 | ROB 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 | AUTO*THERM SHORTWAVE DIATHERMY |
| Generic Name | ME 300 |
| Product Code | IMJ |
| Date Received | 2015-08-03 |
| Model Number | ME 300 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP. |
| Manufacturer Address | 1333 SOUTH CLAUDINA ST. ANAHEIM CA 92805 US 92805 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-03 |