MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-31 for COLLODIAN COLODIAN manufactured by Mavidon Medical Products.
[2578316]
Patient wrote complaint letter to the hospital stating that she had experienced significant hair loss where the eeg electrodes had been glued to her head (on the seizure monitoring unit). Patient had been hospitalized for 8 days and noted the hair loss after she was home from the hospital. Patient also e-mailed several pictures of the bald spots on her head (where electrodes had been glued). Patients sign a form describing the risks of epilepsy monitoring, which specifically states that ".... Small patches of hair are sometimes lost. " however, the patient's pictures show more than small patches of hair were lost. What was the original intended procedure? Continous eeg monitoring for seizures.
Patient Sequence No: 1, Text Type: D, B5
[9951434]
We contacted the initial reporter and she would not give us any further information including lot numbers, an update on the patient conditions etc... In general, using any type of adhesive, like the collodion or tapes, on the skin for a long period of time will result in suffocation of the hair follicles where they will temporarily fall out. The mavidon colodian was used on conjunction with other medical devices from other companies including ecg pads, ecg gel, ecg machine and the adhesive removers at the end of the procedure. The report does not mention if the electrodes were attached for 8 days straight of if they removed them periodically. Either way, the risk of temporary hair loss for extended monitoring is a known and acceptable risk. In fact the facility had the patient sign a form describing the potential of this. We have not seen the pictures described, but the size of the patches usually are in direct relation to the amount of glue and paste (weaver & company) used. The mavidon adhesive remover (collodion remover or medical adhesive remove) is not suspected to have a risk of hair loss.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1064095-2012-00001 |
| MDR Report Key | 2519756 |
| Report Source | 05 |
| Date Received | 2012-03-31 |
| Date of Report | 2012-03-30 |
| Date of Event | 2011-11-29 |
| Date Mfgr Received | 2012-03-02 |
| Date Added to Maude | 2012-08-01 |
| 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 |
| Generic Name | SKIN PREPARATION |
| Product Code | IAW |
| Date Received | 2012-03-31 |
| Model Number | COLODIAN |
| 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. Other | 2012-03-31 |