MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for COLLODION REMOVER manufactured by Mavidon Medical Products.
[175370719]
Mavidon issued a voluntary recall of all products manufactured at their facility including skin preparation cups and remover electrode collodions due to contamination with burkholderia cepacia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092253 |
| MDR Report Key | 9592693 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 REMOVER |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOY |
| Date Received | 2020-01-14 |
| Lot Number | 30218 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON MEDICAL PRODUCTS |
| Brand Name | WAVEPREP HYDRO DOT 8.5 G GRAM(S) |
| Generic Name | DEGREASER, SKIN, SURGICAL |
| Product Code | KOY |
| Date Received | 2020-01-14 |
| Lot Number | 30500 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIOSIGNAL GROUP |
| Product Code | --- |
| Date Received | 2020-01-14 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |