MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-21 for INTELECT MOBILE INT'L STD. 2776 manufactured by Djo, Llc.
[133771237]
Reporter occupation: unknown.
Patient Sequence No: 1, Text Type: N, H10
[133771238]
It was reported that the power supply has burned. There was no patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-2019-00001 |
| MDR Report Key | 8264068 |
| Date Received | 2019-01-21 |
| Date of Report | 2019-04-10 |
| Date of Event | 2018-12-28 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2019-01-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE TX 750679663 |
| Manufacturer Country | US |
| Manufacturer Postal | 750679663 |
| Manufacturer Phone | 7607343126 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTELECT MOBILE INT'L STD. |
| Generic Name | STIMULATOR, ULTRASOUND AND MUSCLE... |
| Product Code | IMG |
| Date Received | 2019-01-21 |
| Model Number | 2776 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | 1430 DECISION STREET VISTA CA 920819663 US 920819663 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-21 |