MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-07 for PEDIPREP MD0033-T manufactured by Mavidon.
[174388751]
Per telephone conversation with company rep, device is recalled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092095 |
| MDR Report Key | 9564448 |
| Date Received | 2020-01-07 |
| Date of Report | 2020-01-06 |
| Date Added to Maude | 2020-01-08 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIPREP |
| Generic Name | SKIN PREP GEL |
| Product Code | OJU |
| Date Received | 2020-01-07 |
| Model Number | MD0033-T |
| Lot Number | 29769 |
| Device Expiration Date | 2020-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIDON |
| Manufacturer Address | LAKE WORTH FL 33461 US 33461 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-07 |