MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-15 for CHATTANOOGO 2760 manufactured by Djo, Llc.
[52093454]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[52093455]
Per 21cfr part 803, an mdr reportable event. Complaint received that alleges i was being treated at a physical therapy office and had two electrodes put on my left hip area for trochanteric bursitis. After the stimulator machine was on for about one minute, i started getting very excruciating soreness in the treated area. Since it was on for only ten minutes, i did not make a connection with the severe burn that resulted. When my therapist came back in the room, the electrodes were removed and when the therapist went to massage the area, the therapist asked if i knew i had some type of pressure sore and did i have any itching, soreness or awareness of the "lesion" that was noticed. I went to my primary care doctor who referred me to a dermatologist. Today, (b)(6) 2016, the dermatologist said it had not healed at all and did a biopsy. I also had my physical med rehab doctor check it out and as soon as he saw the "lesion/burn/sore", he said i was burned by the electrode. To date, even though i was told it is not infected, i was given an antibiotic ointment to put on once a day. That did not work much at all, just a slight decrease in size of wound. At this point i do not know what to do or which doctor's advice i should listen to. I will most likely get the biopsy results in one week, and i will take it from there. My hip is extremely sore, looks disgusting, and until it is healed, if ever, i cannot have any physical therapy for the original trochanteric bursitis. I do not believe the physical therapist made a report but possibly wrote something in my chart. I am afraid of the wound becoming infected and feel this should be reported in case the equipment malfunctioned or the electrodes were not properly connected. " device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00019 |
| MDR Report Key | 5875609 |
| Report Source | OTHER |
| Date Received | 2016-08-15 |
| Date of Report | 2016-08-15 |
| Date of Event | 2016-06-14 |
| Date Mfgr Received | 2016-08-05 |
| Date Added to Maude | 2016-08-15 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | WILLIAM FISHER |
| Manufacturer Street | 1430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607313126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, MEXICO 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGO |
| Generic Name | INTELECT LEGEND XT COMBOUS STD |
| Product Code | IMG |
| Date Received | 2016-08-15 |
| Model Number | 2760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-15 |