MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-05 for HEMACLEAR MEDIUM YELLOW PRH-040-YE-01 manufactured by Ohk Medical Devices, Inc.
[2205835]
The pt experienced approx 50cm2 avulsion of skin when the hemaclear tournequet was rolled over the pt's forearm. The pt presented with bleeding and a swollen hand and arm from a malfunctioning arteriovenous fistula for dialysis. The arm was measured and then hemaclear tournequet size yellow was rolled over the pt's hand and forearm to assist with hemostasis during the arteriovenous fistula ligation procedure. While the roll-on tournequet was being rolled over the forearm, the skin tore and approx 50cm2 was avulsed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021685 |
| MDR Report Key | 2202226 |
| Date Received | 2011-08-05 |
| Date of Report | 2011-08-05 |
| Date Added to Maude | 2011-08-18 |
| 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 | 3 |
| Health Professional | 3 |
| 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 | HEMACLEAR |
| Generic Name | NONPNEUMATIC TOURNIQUET |
| Product Code | GAX |
| Date Received | 2011-08-05 |
| Model Number | MEDIUM YELLOW |
| Catalog Number | PRH-040-YE-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHK MEDICAL DEVICES, INC |
| Manufacturer Address | HAIFIA, IL-Z 33095 IS 33095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-08-05 |