MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-08-14 for STRETCH LATEX FREE TOURNIQUET 367203 manufactured by Hygenic Corp..
[892743]
Hcw reported some sort of an allergic reaction occurred at the site where the tourniquet was applied. The reaction created a wheal around the pt's arm. The pt was administered benadryl and responded favorably to the medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519375-2008-00001 |
| MDR Report Key | 1120706 |
| Report Source | 05,06,07 |
| Date Received | 2008-08-14 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-08-05 |
| Date Facility Aware | 2008-08-05 |
| Report Date | 2008-08-14 |
| Date Mfgr Received | 2008-08-05 |
| Date Added to Maude | 2009-06-03 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRETCH LATEX FREE TOURNIQUET |
| Generic Name | TOURNIQUET |
| Product Code | GAX |
| Date Received | 2008-08-14 |
| Model Number | NA |
| Catalog Number | 367203 |
| Lot Number | 8B001 |
| 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 CORP. |
| Manufacturer Address | 1245 HOME AVE AKRON OH 44310 US 44310 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-14 |