MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-29 for HEMACLEAR / 40 YELLOW PRH 040 YE 01A manufactured by Hemaclear.
[2259637]
Problem is severe pain with hemaclear tourniquet size yellow. Pt has end stage renal disease and was receiving hemodialysis via a right arm arteriovenous fistula. His fistula had malfunctioned because of an aneurysm. He was undergoing surgical repair with local anesthesia with iv sedation. The arm was measured and the yellow hemaclear tourniquet selected. Local anesthesia of 1% lidocaine was given and sedation with versed and fentanyl was given. After application of the tourniquet to the right forearm the pt complained of severe pain in the area of the elastic tourniquet ring. The tourniquet was cut off and the pain quit. A pneumatic tourniquet 18 inches was applied and the arm re-exsanguinated and then the tourniquet inflated to 250 mm hg pressure. There were no further problems during the operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5022457 |
| MDR Report Key | 2276033 |
| Date Received | 2011-09-29 |
| Date of Report | 2011-09-29 |
| Date of Event | 2011-09-29 |
| Date Added to Maude | 2011-10-07 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMACLEAR / 40 YELLOW |
| Generic Name | ELASTIC TOURNIQUET |
| Product Code | GAX |
| Date Received | 2011-09-29 |
| Returned To Mfg | 2011-09-29 |
| Model Number | PRH 040 YE 01A |
| Lot Number | NZ-0611-08 |
| Device Expiration Date | 2014-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMACLEAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-29 |