MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-02-17 for CHATTANOOGA 27335 manufactured by Djo, Llc.
[38339703]
Not returned
Patient Sequence No: 1, Text Type: N, H10
[38339704]
Complaint received that alleges "patient has burns at the site of application from the unit. The injured party was treated at the hospital/clinic and released". Questionnaire was received from clinician and/or patient. Treatment was not interrupted, however progress toward recovery was impeded. Second (2nd) degree burns were treated with silvedene cream po antibiotic of keflex when observed. Patient also sought additional treatment and received silvedene cream po antibiotic of keflex. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
[50555337]
Product was returned for review. The product met specifications and did not malfunction. The unit and applicator passed functional testing. The leadwires tested within tolerance. However the electrodes were not tested due to the fact that they were not the recommended djo brand and the resistance spec is unknown for these electrodes. Visually the electrodes were dirty and missing gel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2016-00004 |
| MDR Report Key | 5441484 |
| Report Source | USER FACILITY |
| Date Received | 2016-02-17 |
| Date of Report | 2016-07-27 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-07-27 |
| Date Added to Maude | 2016-02-17 |
| 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 | APPLICATOR 5CM BLUE CALIBR |
| Product Code | IMI |
| Date Received | 2016-02-17 |
| Model Number | 27335 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-02-17 |