MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-09-15 for SENIOR SOLUTIONS 2CH STIM PKG 2863 manufactured by Dj Orthopedics De Mexico, S.a. De C.v..
[2195986]
Therapist applied ifc to pt using 2 inch square electrodes and intensity set to pt tolerance. Electrodes used for treatment had been previously used for approx 12 treatments. During ifc treatment, an electrode began to pull away and the therapist discovered area under electrode was red with 2 tiny blisters; skin under remaining three electrodes also had small blisters. Pt stated she did not have a burning sensation and treatment felt the same as when previously applied. Prior to electrode application, skin was cleaned with soap and water; it is unk if (b)(4) electrodes were used during treatment. Medical treatment was interrupted at 12 minutes into a 20 minute session. There was no report of medical intervention. Pt precautions reported as obesity, shortness of breath, and fall precautions. Device user manual (b)(4): states to prepare treatment area by cleaning with medical grade alcohol, describes electrodes in configurations of 2. 75 inch round or 1. 25 inch round, states electrodes are for one time use, to use (b)(4) electrodes whenever possible. Djo considers any report of burn a serious injury and reportable event. Device has not been received for eval.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2011-00102 |
| MDR Report Key | 2255707 |
| Report Source | 06 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-08-17 |
| Date Added to Maude | 2011-09-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Manufacturer G1 | DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. |
| Manufacturer Street | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE |
| Manufacturer City | TIJUANA 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENIOR SOLUTIONS 2CH STIM PKG |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMJ |
| Date Received | 2011-09-15 |
| Model Number | 2863 |
| Lot Number | ELECTRODE: 030224 |
| 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, S.A. DE C.V. |
| Manufacturer Address | 20230 SUBMETROPOLI EL FLORIDO CARRETERA LIBRE TIJUANA TECATE TIJUANA 22244 MX 22244 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-15 |