MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-10 for CHATTANOOGA 27812 manufactured by Djo, Llc.
[74830474]
Not returned.
Patient Sequence No: 1, Text Type: N, H10
[74830475]
Complaint received that alleges "she had received treatment to her face for tmj without glasses. Since the treatment she has had troubles with distorted vision, her eyes hurt and are hard to keep open, and she has had some spells of dizziness. She sought help from her optometrist but they were unable to give clear answer". Questionnaire not received from customer or clinician. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2017-00009 |
| MDR Report Key | 6557202 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-10 |
| Date of Report | 2017-05-10 |
| Date of Event | 2017-05-04 |
| Date Added to Maude | 2017-05-10 |
| 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 920819663 |
| Manufacturer Country | US |
| Manufacturer Postal | 920819663 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, 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 9CLS 5X200MW 1040MW |
| Product Code | ILY |
| Date Received | 2017-05-10 |
| Model Number | 27812 |
| 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 | 2017-05-10 |