MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-10-05 for INTELECT 2761 manufactured by Djo Global.
[2216409]
Unit reported to have burned two pts causing blisters.
Patient Sequence No: 1, Text Type: D, B5
[9432972]
The original unit (b)(4) mentioned in the customer complaint passed visual and functional testing upon return. The lead wires (b)(4) and applicators (b)(4) showed wear and did not pass visual or functional testing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2011-00123 |
| MDR Report Key | 2288302 |
| Report Source | 00 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-10-05 |
| Date of Event | 2011-09-15 |
| Date Added to Maude | 2012-07-06 |
| 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 Street | 1430 DECISION ST. |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELECT |
| Generic Name | ELCTROTHERAPY |
| Product Code | IMG |
| Date Received | 2011-10-05 |
| Returned To Mfg | 2011-09-30 |
| Catalog Number | 2761 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO GLOBAL |
| Manufacturer Address | VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-05 |