MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-16 for SENIOR SOLUTION SHORTWARE 1601 manufactured by Dj Orthopedics De Mexico.
[2197821]
Clinician reported that during therapy, blisters were observed under the electrode pads.
Patient Sequence No: 1, Text Type: D, B5
[9326973]
User reported that during therapy blisters were observed under the electrode pads. While pt stated at no point did she have burning sensation during the therapy it cannot be assumed the blisters were not caused by the device. As the device has not been returned to djo, as of 09/16/2011 eval of device has not been performed. If further relevant info is obtain a f/u report will be completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616086-2011-00103 |
| MDR Report Key | 2256979 |
| Report Source | 05 |
| Date Received | 2011-09-16 |
| Date of Report | 2011-09-16 |
| Date of Event | 2010-08-17 |
| Date Mfgr Received | 2011-06-23 |
| Date Added to Maude | 2011-09-22 |
| 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 | 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 | SENIOR SOLUTION SHORTWARE |
| Generic Name | ELECTROTHERAPY |
| Product Code | IMJ |
| Date Received | 2011-09-16 |
| Model Number | 1601 |
| 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 | 2011-09-16 |