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 |