MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-04 for COLLODION * manufactured by Mavidon.
[1216254]
I had a sleep study done at sleep insights and they used collodion to have the electrodes to stick to my head and about a month after my sleep study, my hair started to fall out leaving me with patches of bald spots where the collodion was to stick the electrodes to my head.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5012263 |
| MDR Report Key | 1432371 |
| Date Received | 2009-08-04 |
| Date of Report | 2009-08-04 |
| Date Added to Maude | 2009-08-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLODION |
| Generic Name | COLLODION |
| Product Code | KOY |
| Date Received | 2009-08-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-08-04 |