MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-22 for INTELLECT MOBILE COMBO 2778 manufactured by Dj Orthopedics De Mexico.
[2163371]
Event was reported from an international (b)(6) clinician that he observed what was identified as burns or scarring in the treatment area of a patient during a follow up visit. The clinician indicated there was no need to interrupt therapy or provide medical intervention. The clinical facility possesses three (3) cat. # 2778 intellect mobile combo devices, but could not be certain which device the therapy was provided. The device has not yet been received by djo for evaluation but it could be reasonably assumed that the device may have contributed to the adverse event.
Patient Sequence No: 1, Text Type: D, B5
[9328122]
Device has not been received from clinician as of (b)(4)2011 (b)(6) supplemental report, if relevant data becomes available, will be submitted to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2011-00117 |
| MDR Report Key | 2265504 |
| Report Source | 05 |
| Date Received | 2011-09-22 |
| Date of Report | 2011-09-22 |
| Date of Event | 2011-08-23 |
| Date Mfgr Received | 2011-06-23 |
| Date Added to Maude | 2011-09-28 |
| 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 | A430 DECISION STREET |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607343047 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO |
| Manufacturer City | TIJUANA B.C. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTELLECT MOBILE COMBO |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMG |
| Date Received | 2011-09-22 |
| Model Number | 2778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJ ORTHOPEDICS DE MEXICO |
| Manufacturer Address | TIJUANA B.C. 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-22 |