MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-03 for LEG SENSOR V6 LEFT OR RIGHT TP 7000-0100-01 manufactured by Compumedics.
[17975289]
Three patients received burns on legs at the site where a leg sensor was applied during sleep study testing. First patient and second patient, (b)(6), notified sleep center of burns on (b)(6) 2012. Date of burns (b)(6) 2012. Third patient notified office during a follow up visit on (b)(6) 2012, (b)(6). That he received a burn on leg when in for testing on (b)(6) 2012. Pictures from patient, (b)(6), were forwarded to sleep center and there appeared to be a raised blister at the site of where leg sensors were attached. No medical treatment was received by any of these patients to determine if an allergic reaction or chemical burn may have caused burn. Also see (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025310 |
| MDR Report Key | 2565393 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-05-03 |
| Date of Event | 2012-04-15 |
| Date Added to Maude | 2012-05-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | LEG SENSOR V6 LEFT OR RIGHT TP |
| Generic Name | "LEG PADDLES" |
| Product Code | LEL |
| Date Received | 2012-05-03 |
| Returned To Mfg | 2012-04-25 |
| Model Number | 7000-0100-01 |
| Lot Number | ITEMS RETURNED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMPUMEDICS |
| Manufacturer Address | 30-40 FLOCKHART ST ABBOTSFORD VIC 3067 AS 3067 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-03 |