MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-03-07 for INTELECT LEGEND INTC B manufactured by Chattanooga Group.
[1914921]
Pt is a female, (b)(6), with the pre-existing conditions: lumbar stenosis, diabetes, cva with left hemiplegia, aurally foot drop, cad. On (b)(6) 2011, the pt was given her 5th session of interferential therapy for 20 mins. The pt did not complain during or after the treatment. However she complained soreness and development of a "blister" when she returned for her next visit on (b)(6) 2011. She returned for 3 add'l physical therapy sessions after the incident, but has advice put herself on "hold". The treatment is to decrease muscle spasm of left piriformis. Moist heat is also used to treat muscle spasm. She consulted wound care specialist who advised debridement as easily able with tweezers and wash cloth, apply desitin to keep moist. The condition of the burn is partial thickness and second degree. The pt participated in exercise prior to interferential estim and heat therapy. She was positioned in right side lying with pillow between her legs with hot pack cloth over her hip and buttock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1022819-2011-00003 |
| MDR Report Key | 2015748 |
| Report Source | 99 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-03-04 |
| Date of Event | 2011-01-07 |
| Date Mfgr Received | 2011-02-03 |
| Date Added to Maude | 2012-05-24 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607343047 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT LEGEND |
| Generic Name | NONE |
| Product Code | IMI |
| Date Received | 2011-03-07 |
| Returned To Mfg | 2011-02-16 |
| Model Number | INTC B |
| Catalog Number | INTC B |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHATTANOOGA GROUP |
| Manufacturer Address | 4717 ADAMS RD. HIXSON TN 37343 US 37343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-03-07 |