MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-06-10 for CARE IFC PLUS CIFC manufactured by Care Rehab And Orthopaedic Products, Inc..
[861805]
Pt stated that the care ifc plus would shock her if she moved slightly. The pt stated that she had been using the device for 1. 5 to 2 months when she started to experience shocking sensations. She looked at the instructions and thought maybe the electrodes were not making good contact with her skin. She tried 3 separate sets of electrodes at the same setting (150) and had the same shocking sensation each time.
Patient Sequence No: 1, Text Type: D, B5
[8004507]
Our devices are all battery powered devices and work to stimulate nerves and muscles via small electrical currents. In normal use and operation, many pts will describe the completely normal sensations created as "shocking" to some degree. The company's investigation of this event determined that this incidence of "shocking" was not a "serious injury" as defined by 21 cfr 803 and that no evidence was uncovered that indicates a reportable device malfunction occurred. Even though this incident does not appear to meet the definition of an mdr reportable event, the investigation was still ongoing past the 30 day threshold. In an abundance of caution, care rehab, inc. (cri) is submitting this retrospective mdr to ensure compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1124681-2008-00003 |
| MDR Report Key | 1059616 |
| Report Source | 04 |
| Date Received | 2008-06-10 |
| Date of Report | 2007-09-21 |
| Date of Event | 2007-09-21 |
| Date Mfgr Received | 2007-09-21 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2009-04-29 |
| 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 Contact | DAVE MUROSKI, OFFICER |
| Manufacturer Street | 3930 HORSESHOE BEND ROAD |
| Manufacturer City | KEYSVILLE VA 23947 |
| Manufacturer Country | US |
| Manufacturer Postal | 23947 |
| Manufacturer Phone | 4347369799 |
| Manufacturer Street | 3930 HORSESHOE BEND ROAD |
| Manufacturer City | KEYSVILLE VA 23947 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 23947 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARE IFC PLUS |
| Generic Name | INFERENTIAL CURRECT THERAPY |
| Product Code | LIH |
| Date Received | 2008-06-10 |
| Returned To Mfg | 2008-01-25 |
| Model Number | CIFC |
| Lot Number | 0605 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARE REHAB AND ORTHOPAEDIC PRODUCTS, INC. |
| Manufacturer Address | 3930 HORSESHOE BEND ROAD KEYSVILLE VA 23947 US 23947 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-06-10 |