MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-23 for CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPL 2778 manufactured by Djo, Llc.
[184492113]
No device was returned for evaluation. If the device is received, a follow-up report will be submitted upon completion of product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[184492134]
It was reported that the intensity goes up on its own and cannot be controlled; it gets very high and shocked a patient. No further information is currently available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2020-00012 |
| MDR Report Key | 9864812 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-22 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-23 |
| 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 | BRIAN BECKER |
| Manufacturer Street | 2900 LAKE VISTA DRIVE |
| Manufacturer City | LEWISVILLE, TX |
| Manufacturer Country | US |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | CARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO |
| Manufacturer City | TIJUANA, B.C. 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPL |
| Generic Name | STIMULATOR, MUSCLE, POWERED |
| Product Code | IPF |
| Date Received | 2020-03-23 |
| Model Number | 2778 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |