MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-06-08 for COLLODION 11 * manufactured by Mavidon.
[2670439]
A patient had a 24-hour eeg leads placed using collodion and was sent home. The patient began to feel very hot, sweating, itching and with red color spots on her head. She was send to the ed (emergency department). In the ed, the patient was noted having an allergic reaction with shortness of breath, throat swelling, hives, dizziness, tachycardia, and expiratory wheezes. Oxygen was applied; albuterol via nebulizer and epinephrine subcutaneous was administered. The patient's head was shaved to remove all traces of glue believed to be causing the reaction. Patient was stabilized and discharged home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2613797 |
| MDR Report Key | 2613797 |
| Date Received | 2012-06-08 |
| Date of Report | 2012-06-08 |
| Date of Event | 2012-05-31 |
| Report Date | 2012-06-08 |
| Date Reported to FDA | 2012-06-08 |
| Date Added to Maude | 2012-06-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | COLLODION 11 |
| Generic Name | COLLODION 11, ETHER FREE |
| Product Code | IAW |
| Date Received | 2012-06-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON |
| Manufacturer Address | 1820 2ND AVE NO LAKE WORTH FL 33461 US 33461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-08 |