MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-12 for COLLODIAN II MDCOLII manufactured by Mavidon Medical Products.
[2832620]
A patient had a 24 hour eeg lead placed using collodion and was sent home. The patient began to feel very hot, sweating, itching and red color spots on her head. She was sent to the ed (emergency department). In the ed the patient was noted as 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
[10054688]
During the eeg procedure as described in this report there are a number of items that were used during the procedure: nuprep by weaver and company; ten20 conductive past by weaver and company; electrodes by nihon kohden; collodion ii by mavidon. The suspected medical device in the report was collodion ii. This is a fast drying adhesive made with ethyl acetate and isopropanol as the solvents and cellulose nitrate (nitrocellulose) is the resin. Once the solvents evaporate the only remaining ingredient is nitrocellulose. Nitrocellulose is commonly used in other skin contact products such as compound w and new skin liquid bandage. We have never received any complaints of this type in the past for collodion ii. Nuprep skin prep is used to clean the electrode site and will leave a residue of the gel until cleaned after the procedure. The ten20 conductive past remains on the patient throughout the procedure. We noticed in section 7 that the patient has a history of many allergies. Though we cannot absolutely say collodion ii did not cause this reaction, we must also look at the other products used since they remain on the skin for longer periods of time which may or may not cause an allergic reaction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1064095-2012-00002 |
| MDR Report Key | 2660730 |
| Report Source | 05 |
| Date Received | 2012-07-12 |
| Date of Report | 2012-07-09 |
| Date of Event | 2012-05-31 |
| Date Mfgr Received | 2012-06-14 |
| Date Added to Maude | 2012-07-31 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1820 2ND AVENUE NORTH |
| Manufacturer City | LAKE WORTH FL 33461 |
| Manufacturer Country | US |
| Manufacturer Postal | 33461 |
| Manufacturer Phone | 5615852227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLODIAN II |
| Generic Name | COLLODION |
| Product Code | IAW |
| Date Received | 2012-07-12 |
| Model Number | MDCOLII |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON MEDICAL PRODUCTS |
| Manufacturer Address | LAKE WORTH FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-07-12 |