MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-09 for CHATTANOOGA 7560 manufactured by Djo, Llc.
[44725019]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[44725020]
Complaint received that alleges "electrodes were getting uncomfortably hot. The customer turned the unit down to level one, then turned the unit off. The electrodes shocked the customer as he removed the electrodes from the patient. The lower two electrodes were very hot. At the next visit the patient made customer aware of blisters at the site of the injury. The patient came in on friday (b)(6) 2016 with open wounds. Customer is calling a wound center". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2016-00014 |
| MDR Report Key | 5640861 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-09 |
| Date of Report | 2016-05-09 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-04-26 |
| Date Added to Maude | 2016-05-09 |
| 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 | 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 | CHATTANOOGA |
| Generic Name | INTELECT 4CH STIM PKG |
| Product Code | IMI |
| Date Received | 2016-05-09 |
| Model Number | 7560 |
| 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. Other | 2016-05-09 |