MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-21 for HYSYNAL SYNTHETIC RUBBER TOURNIQUETS NONE manufactured by The Hygenic Corporation.
[1728050]
Tourniquet applied to arm for obtaining blood specimen. Phlebotomist suffered allergic reaction requiring medical treatment. On reviewing the problem, 5 other staff people also suffered tingling in oral structures, respiratory discomfort, and in one case, nausea. Product is clearly labeled "non-latex" but also has an extremely strong odor that is noxious. Product is covered with a powder. We are unable to determine what caused the allergy symptoms. Company was notified. ====================== health professional's impression======================the staff involved all remarked about the strong odor and the powder that "is supposed to cover the strong odor" per the company. ======================manufacturer response for tourniquet for accessing veins, hysynal synthetic rubber tourniquets======================denied having any problems with this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1978933 |
| MDR Report Key | 1978933 |
| Date Received | 2011-01-21 |
| Date of Report | 2011-01-21 |
| Date of Event | 2011-01-10 |
| Report Date | 2011-01-21 |
| Date Reported to FDA | 2011-01-21 |
| Date Added to Maude | 2011-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYSYNAL SYNTHETIC RUBBER TOURNIQUETS |
| Generic Name | TOURNIQUET FOR ACCESSING VEINS |
| Product Code | GAX |
| Date Received | 2011-01-21 |
| Model Number | TOURNIQUET |
| Catalog Number | NONE |
| Lot Number | 10204347T1 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVENUE AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-21 |