MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for SOMATICS EPAD manufactured by Somatics, Llc.
[139856773]
Patient received an ect treatment. During treatment doctor noticed a burning smell. When the patient was in pacu, the nurse noticed a small burn where the thymapad had been. The patient also had a metal rod pierced through the eyebrow near the skin burn site. The skin was treated with bacitracin and the patient sent home. No further treatments were administered to the skin. The patient was told to remover the metal rod before any further ect treatments. This event was reported to the fda by the risk management of the hospital, 12/10 2013, number mw3516403. At that time, somatics did not consider this an event caused by the thymapad, rather the metal piercing. The patient was told to remove the metal rod before any further ect treatment and the patient was sent home after the bacitracin application with no further medical treatments. This led the company to consider the thymapad was not the cause of the event. Upon further consideration the company has determined that it should report this event out of abundance of caution and to ensure full compliance with 21 cfr part 803. [mw 3516403. Pdf].
Patient Sequence No: 1, Text Type: N, H10
[139856774]
Patient with a metal rod inserted in the eyebrow received an ect treatment with a thymapad stimulus electrode. During the treatment, the physician smelled a burning odor. In the pacu, the nurse removed the thymapad and noticed a very small skin burn. The skin was treated with bacitracin and the patient was sent home. The patient was told to remove the metal rod prior to receiving any future ect treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420295-2019-00003 |
| MDR Report Key | 8445243 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-21 |
| Date of Event | 2013-11-29 |
| Date Mfgr Received | 2013-12-12 |
| Date Added to Maude | 2019-03-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID MIRKOVICH |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal | 34292 |
| Manufacturer Phone | 8006426761 |
| Manufacturer G1 | SOMATICS, LLC |
| Manufacturer Street | SUITE 101 720 COMMERCE DRIVE |
| Manufacturer City | VENICE FL 34292 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34292 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 3516403 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SOMATICS |
| Generic Name | THYMAPAD STIMULUS ELECTRODE |
| Product Code | GXY |
| Date Received | 2019-03-22 |
| Model Number | EPAD |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SOMATICS, LLC |
| Manufacturer Address | SUITE 101 720 COMMERCE DRIVE VENICE FL 34292 US 34292 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |