MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-20 for LAMINARIA * manufactured by British Marketing Enterprises.
[20524699]
This is a concern about lack of an exp date on a product that has the warning "caution federal law restricts this device to sale by or on the order of a physician": laminaria - cervical dilators - marketed by british marketing enterprises. There is a date on the box that 1 would take as an exp date however on calling the co to be sure, they stated this was the date it was packaged and sterilized and it is good for 3 yrs from that date. We had 1 box that was dated 0505 - that was recently found - and it was assumed it was long expired. Can you suggest they put the exp date on with this other date?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1039818 |
| MDR Report Key | 748882 |
| Date Received | 2005-07-21 |
| Date of Report | 2006-07-20 |
| Date Added to Maude | 2006-08-16 |
| 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 | PHARMACIST |
| 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 | LAMINARIA |
| Generic Name | SEAGROWN PLANT |
| Product Code | HDY |
| Date Received | 2006-07-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | NONE OF ANY OF THIS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 736663 |
| Manufacturer | BRITISH MARKETING ENTERPRISES |
| Manufacturer Address | * PETALUMA CA 94954 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-07-21 |