MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-04-01 for IF II 7100S * manufactured by Rehabilicare Inc..
[130195]
Pt was recieving stimulation on lumbar area at hosp physical therapy clinic. Aa alkaline batteries "popped" and pt felt shock. Pt believes she may have "blacked out" temporarily. Pt was taken to emergency room, rec'd some pain medication and sent home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126518-1999-00001 |
| MDR Report Key | 216849 |
| Report Source | 05,06 |
| Date Received | 1999-04-01 |
| Date of Report | 1999-03-31 |
| Date of Event | 1999-02-15 |
| Date Facility Aware | 1999-02-15 |
| Report Date | 1999-03-31 |
| Date Mfgr Received | 1999-03-08 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 1999-04-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IF II |
| Generic Name | INTERFERENTIAL STIMULATION |
| Product Code | LIH |
| Date Received | 1999-04-01 |
| Returned To Mfg | 1999-03-08 |
| Model Number | 7100S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 210349 |
| Manufacturer | REHABILICARE INC. |
| Manufacturer Address | 1811 OLD HIGHWAY 8 NEW BRIGHTON MN 55112 US |
| Baseline Brand Name | IF II |
| Baseline Generic Name | INTERFERENTIAL STIMULATION |
| Baseline Model No | 7100S |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1999-04-01 |