MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-02 for COPPERFIT KNEE SLEEVE * manufactured by Copperfit.
[4571296]
I bought a copperfit compression knee compression kit that was advertised as having a "therapeutic copper, essential to your body. Two technologies combined [copper and compression] to help provide support for muscle soreness. " after using this product for a few weeks, i noted that i didn't have any more support for my muscle soreness than when i wore an elastic compression device with no copper infused in it. The copperfit device was "much" more expensive than the simple elastic compression device i bought from my local target store.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5036523 |
| MDR Report Key | 3866833 |
| Date Received | 2014-06-02 |
| Date of Report | 2014-05-30 |
| Date of Event | 2014-05-01 |
| Date Added to Maude | 2014-06-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPPERFIT KNEE SLEEVE |
| Generic Name | COPPERFIT KNEE SLEEVE |
| Product Code | FQL |
| Date Received | 2014-06-02 |
| Model Number | KNEE SLEEVE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SIZE MEDIUM |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPPERFIT |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-02 |