MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-13 for INTELECT TRANSPORT COMBO PKG 2738 manufactured by Djo Global.
[19845796]
The original complaint assessment completed on (b)(4) 2011 indicated that the pt was shocked but no burn and that the device was returned and found to be within spec. The subsequent questionnaire received 09/13/11 indicated that the (b)(6) pt weight of approx (b)(6) with a pre-existing condition of arthritis returned to the clinic approx 18 hrs later with an approx 2 cm blister over the treated area. Pt was being treated with ultrasound for a right shoulder strain. Constant current was used with movement of applicator 2-3 cm/sec. Treatment was not interrupted nor was progress toward recover impeded due to the incident. It was later that the pt returned with blister. Pt may have been seen by a referring physician for the burn but this has not been confirmed. Djo global defines a burn as mdr reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00101 |
| MDR Report Key | 2251408 |
| Report Source | 99 |
| Date Received | 2011-09-13 |
| Date of Report | 2011-09-13 |
| Date of Event | 2011-07-28 |
| Date Added to Maude | 2011-09-19 |
| 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 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO |
| 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 | INTELECT TRANSPORT COMBO PKG |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMI |
| Date Received | 2011-09-13 |
| Model Number | 2738 |
| Catalog Number | 2738 |
| 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 | 2011-09-13 |