MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-03-08 for SYS STIM ME220 manufactured by Mettler Electronics Corp..
[3376281]
On (b)(4) 2013 i received a call from (b)(6) - she stated that a male pt was treated with an me220 (muscle stimulator) on three different occasions ((b)(6) 2012). Allegedly upon the third visit ((b)(6) 2012) it was noticed that the pt had a small (3rd degree) burn - about the size of a cigarette on his back (he was being treated for back injuries due to an automobile accident). There are no pictures of alleged burn. The pt left the office and nothing more happened - until now, almost one year later, when the pt has now obtained a lawyer and is allegedly filing a lawsuit against (b)(6). Since the alleged incident, (b)(6)has continued to use said device and has had no issues. Upon notification of the lawsuit, mettler instructed (b)(6) to submit the device to mettler for investigation - thus the device was received at mettler on (b)(4) 2013.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013558-2013-00001 |
| MDR Report Key | 3001714 |
| Report Source | 06,07 |
| Date Received | 2013-03-08 |
| Date of Report | 2013-03-07 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2013-03-06 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2013-03-14 |
| 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 | CHRISTINA CAYUELA, MGR. |
| 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 | SYS STIM ME220 |
| Generic Name | MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2013-03-08 |
| Returned To Mfg | 2013-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | METTLER ELECTRONICS CORP. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-03-08 |