MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-12-12 for CHATTANOOGA 2761 manufactured by Djo, Llc.
[94619762]
Complaint received that alleges "during an interferential e-stem treatment for a muscle spasm on channel 2 and 3 a patient received a burn under two electrode pads. The patient was instructed that the intensity should be strong but not painful, and they needed to indicate when the intensity was sufficient for them, which he did so. About 2-3 minutes into the 12 minute treatment he asked for it to be turned down, which it was until he indicated it was a better intensity. About 3-4 minutes later he again asked for it to be turned down, which again it was until he indicated it was better. After about a minute he complained of it feeling hot/ burning despite not having any heat packs or ice associated with the treatment. He was told that was not normal, and he had the choice to continue with the treatment and keep turning it down, or that he could terminate the treatment. He chose to turn it down again, and after about 1 minute asked for it to be turned off. There was about 2 minutes left on the treatment. The treatment was given under his shirt to his rhomboid, the leads were removed and he went to the locker room. He returned to show me his burns, and his wounds were cleaned, treated with hydrocortisone cream and covered with a bandage. At the same time as his treatment another patient was receiving an ultrasound, stem combo treatment on channels 2 and the ultrasound head. There were no problems with the combo treatment administered. Follow-up with urgent care facility where he was told he had 3rd degree burns that would need future debridement and a referral to a wound care facility". Device not received manufacturer at this time.
Patient Sequence No: 1, Text Type: D, B5
[111062218]
Device evaluation report - the product met specifications and did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2017-00022 |
| MDR Report Key | 7109689 |
| Report Source | USER FACILITY |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2017-12-12 |
| 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 | WILLIAM FISHER |
| Manufacturer Street | 1460 DECISION STREET |
| Manufacturer City | VISTA CA 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MX 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL |
| Product Code | IMG |
| Date Received | 2017-12-12 |
| Returned To Mfg | 2018-05-16 |
| Model Number | 2761 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1460 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-12 |