MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-26 for CHO-PAT COUNTER FORCE KNEE WRAP CPCKW97 manufactured by Medi - Dyne Healthcare Products Ltd.
[4040002]
The top of device slid down and bunched up behind there putting pressure on popliteal artery. Being an emt, i immediately remained it before damage could occur. The top strap does not hold the device in place. The top half of the brace slips down behind the knee, cutting off blood flow from the popliteal artery. Reduced circulation in extremity. Additional info: date the person first started taking or using the product on: (b)(6) 2013; date the person stopped taking or using the product on: (b)(6) 2013. Did the problem stop after the person reduced the dose or stopped taking or using the product: yes. Did the problem return if the person started taking or using the product again? : didn't restart. Why was the person using the product: knee support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033202 |
| MDR Report Key | 3501893 |
| Date Received | 2013-11-26 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-11-18 |
| Date Added to Maude | 2013-12-09 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHO-PAT COUNTER FORCE KNEE WRAP |
| Generic Name | CHO-PAT COUNTER FORCE KNEE WRAP |
| Product Code | KFX |
| Date Received | 2013-11-26 |
| Model Number | CPCKW97 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDI - DYNE HEALTHCARE PRODUCTS LTD |
| Manufacturer Address | PO BOX 1649 COLLEYVILLE TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-26 |