MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for CHATTANOOGA 2761 manufactured by Djo, Llc.
[143682500]
Patient was being ultrasound with unit and reported a sensation of being stabbed with a needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8568480 |
| MDR Report Key | 8568480 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-25 |
| Date of Event | 2019-04-17 |
| Report Date | 2019-04-25 |
| Date Reported to FDA | 2019-04-25 |
| Date Reported to Mfgr | 2019-05-01 |
| Date Added to Maude | 2019-05-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMG |
| Date Received | 2019-05-01 |
| Model Number | 2761 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |