MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-03 for LAMICEL * manufactured by Merocel.
[603422]
Medications for the similar names. Obstetrics requested that pharmacy stock lamicel and we thought they meant lamisil, the anti fungal. But, lamicel is a synthetic osmotic cervical dilator used to induce labor. Mfr is merocel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042470 |
| MDR Report Key | 835877 |
| Date Received | 2007-04-03 |
| Date of Report | 1999-11-09 |
| Date Added to Maude | 2007-04-11 |
| 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 |
| 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 | LAMICEL |
| Generic Name | * |
| Product Code | HDX |
| Date Received | 2007-04-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 823171 |
| Manufacturer | MEROCEL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-03 |