MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-02-25 for APPLICATOR 5CM LEGEND XT 27383 manufactured by Chattanooga Group.
[1067722]
The occupational therapist reported the patients complained of pain during ultrasound treatment. No patient injuries were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[8182273]
During the investigation interview, the clinician did not indicate the number of patients, treatment locations, or treatment settings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2009-00039 |
| MDR Report Key | 1327293 |
| Report Source | 05 |
| Date Received | 2009-02-25 |
| Date of Report | 2009-01-29 |
| Date Mfgr Received | 2009-01-29 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2009-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL TREAS |
| Manufacturer Street | 4717 ADAMS RD. |
| Manufacturer City | HIXSON TN 37343 |
| Manufacturer Country | US |
| Manufacturer Postal | 37343 |
| Manufacturer Phone | 4238702281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APPLICATOR 5CM LEGEND XT |
| Generic Name | ULTRASOUND APPLICATOR, THERAPY |
| Product Code | IMI |
| Date Received | 2009-02-25 |
| Returned To Mfg | 2009-02-04 |
| Model Number | 27383 |
| Catalog Number | 27383 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-25 |