MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-26 for NUPREP GEL 10-30 manufactured by D.o. Weaver And Co.
[19673231]
Pt experienced hives and difficulty breathing after nuprep was applied to skin. Tech had done a pre-test of nuprep on pt's skin and pt had no reactions. Then about 20 minutes into the test, pt started forming hives, but said she was fine. Soon after, pt experienced trouble breathing and was taken to (b)(6). From there she was taken to the hosp, where she was administered an epinephrine shot. Pt was fine after that.
Patient Sequence No: 1, Text Type: D, B5
[19785463]
F/u on (b)(6) 2012, with tech indicated that the pt was indeed fine after the epinephrine shot. The tech believes that pt must be allergic to something in nuprep, and this is what caused the skin hives and difficulty breathing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718791-2012-00005 |
| MDR Report Key | 2512323 |
| Report Source | 05 |
| Date Received | 2012-03-26 |
| Date of Report | 2012-03-26 |
| Date of Event | 2012-02-28 |
| Date Mfgr Received | 2012-03-01 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2012-04-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NICHOLAS LEE |
| Manufacturer Street | 565 NUCLA WAY UNIT B |
| Manufacturer City | AURORA CO 80011 |
| Manufacturer Country | US |
| Manufacturer Postal | 80011 |
| Manufacturer Phone | 3033661804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUPREP GEL |
| Generic Name | NUPREP |
| Product Code | GYB |
| Date Received | 2012-03-26 |
| Model Number | 10-30 |
| Catalog Number | 10-30 |
| Lot Number | 593 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O. WEAVER AND CO |
| Manufacturer Address | AURORA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-26 |