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 SPORT CIFS manufactured by Care Rehab And Orthopaedic Products, Inc..
[21387789]
Returns processing received ifc sport device from sales rep. Attached with the device was a rect (returns/exchange/complaint/transfer) form filled out stating that the device "burned pt severely". When the pt was contacted about the incident, he related that the work "severe" was an overstatement. He said that 2-3 blisters about the size of a 50 cent piece formed but after the device and electrodes were replaced he had no other problems. He stated his blisters cleared up in about a week, and he did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
[21436471]
The company's investigation of this event determined that this burn 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 at 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 | 1124681-2008-00004 |
| MDR Report Key | 1059614 |
| Report Source | 04 |
| Date Received | 2008-06-10 |
| Date of Report | 2007-07-10 |
| Date of Event | 2007-07-10 |
| Date Mfgr Received | 2007-07-10 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2009-05-04 |
| 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 | 3 |
| 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 SPORT |
| Generic Name | INFERENTIAL CURRENT THERAPY |
| Product Code | LIH |
| Date Received | 2008-06-10 |
| Returned To Mfg | 2007-07-10 |
| Model Number | CIFS |
| Lot Number | L02 |
| 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 |