MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2008-01-22 for INTELECT MOBILE COMBO 2778 manufactured by Chattanooga Group.
[17256073]
Unit reported as having high stimulation output when using 2p interferential. No reported injury treatment and/or post injury treatment was noted from the complainant.
Patient Sequence No: 1, Text Type: D, B5
[17313124]
Unit was found to have intermittent stim operation. Replaced stim board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1022819-2008-00019 |
| MDR Report Key | 983338 |
| Report Source | 01,08 |
| Date Received | 2008-01-22 |
| Date of Report | 2008-01-17 |
| Date of Event | 2007-11-21 |
| Date Mfgr Received | 2007-11-28 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2008-04-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT MOBILE COMBO |
| Generic Name | POWER MUSCLE STIMULATOR |
| Product Code | LIH |
| Date Received | 2008-01-22 |
| Returned To Mfg | 2007-11-28 |
| Model Number | 2778 |
| Catalog Number | 2778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 987782 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | HIXSON TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-22 |