MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2011-05-24 for BD VACUTAINER STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Hygenic Corporation.
[2001157]
The customer reported that the patient had an instant local reaction followed moments later by hives. The patient was given benadryl an half an hour (1/2 hr) later, he/she was sent home.
Patient Sequence No: 1, Text Type: D, B5
[9021605]
The bd vacutainer stretch latex free tourniquet is made specifically for practitioners and the facilities that choose to eliminate latex from their health care products. This product is made with synthetic polyisoprene which will not cause a latex-induced allergic reaction in latex-sensitive patients or employees. This device has a vanilla scent that masks the natural odor of the product. The customer indicated that there were no samples available to return. A complaint history review was performed and this is the first recorded complaint for the identified lot. All batch records associated with the lot were reviewed and the raw materials as well as the processing parameters were within specification. It was also confirmed that there were no changes made to the raw materials, suppliers of raw materials or formulation of the product. The related cytotoxicity, skin sensitization and skin irritation studies do not reveal any evidence that there is a potential for the product to cause an allergic reaction as was reported. Regulatory compliance will continue to monitor this condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1519375-2011-00002 |
| MDR Report Key | 2108672 |
| Report Source | 01,05,07 |
| Date Received | 2011-05-24 |
| Date of Report | 2011-05-24 |
| Date of Event | 2011-04-28 |
| Date Mfgr Received | 2011-04-28 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-06-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Manufacturer Contact | RICH VALES |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018475636 |
| Manufacturer G1 | HYGENIC CORP. |
| Manufacturer Street | 1245 HOME AVE. |
| Manufacturer City | AKRON OH 44310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44310 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER STRETCH LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2011-05-24 |
| Model Number | NA |
| Catalog Number | 367203 |
| Lot Number | 8L004 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGENIC CORPORATION |
| Manufacturer Address | 1245 HOME AVE. AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-24 |