MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-10 for INTELECT 2738 manufactured by Chattanooga Medical Supply, Inc.
[14965631]
Pt reportedly sustained a burn which blistered on her shoulder after ultrasound machine applied over area as part of pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021706 |
| MDR Report Key | 2211452 |
| Date Received | 2011-08-10 |
| Date of Report | 2011-08-03 |
| Date of Event | 2011-07-20 |
| Date Added to Maude | 2011-08-18 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT 2738 |
| Generic Name | ULTRASOUND MACHINE |
| Product Code | IMI |
| Date Received | 2011-08-10 |
| Model Number | 2738 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA MEDICAL SUPPLY, INC |
| Manufacturer Address | 827 INTERMONT RD CHATTANOOGA TN 37415 US 37415 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-10 |