MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-16 for C.A.T. manufactured by North American Rescue.
[17130993]
Combat application tourniquets c-a-t: counterfeit product. I have a real c. A. T, so when i received this one in the mail from (b)(4) it was very evident that is was a counterfeit, it was very poorly made and would break with little effort when used. The vendor on (b)(4) that is selling tough amazon is currently called "(b)(4)". If you search (b)(4) it is evident there are other vendors selling counterfeit c. A. T tourniquets. They do not come in all black for one; the red tab is an important design feature. (b)(4)'s product page is listed here: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5028301 |
| MDR Report Key | 2887569 |
| Date Received | 2012-12-16 |
| Date of Report | 2012-12-16 |
| Date of Event | 2012-05-15 |
| Date Added to Maude | 2012-12-31 |
| 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 | 3 |
| 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 | C.A.T. |
| Generic Name | COMBAT APPLICATION TOURNIQUETS -C-A-T- |
| Product Code | GAX |
| Date Received | 2012-12-16 |
| Returned To Mfg | 2012-05-30 |
| Lot Number | X |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NORTH AMERICAN RESCUE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-16 |