MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-26 for ULTRASOUND APPLICATOR 2 CM SQ P/N 78048 NA manufactured by Chattanooga; Djo Orthopedics Llc.
| Report Number | 2478632 |
| MDR Report Key | 2478632 |
| Date Received | 2012-02-26 |
| Date of Report | 2012-02-24 |
| Date of Event | 2011-12-22 |
| Report Date | 2012-02-24 |
| Date Reported to FDA | 2012-02-26 |
| Date Added to Maude | 2012-03-05 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRASOUND APPLICATOR 2 CM SQ |
| Generic Name | ULTRASOUND APPLICATOR 2 CM SQ |
| Product Code | IMI |
| Date Received | 2012-02-26 |
| Model Number | P/N 78048 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA; DJO ORTHOPEDICS LLC |
| Manufacturer Address | 1430 DECISION ST VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-26 |