MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-08 for LAMINARIA JAPONICA THIN * manufactured by Milex Products, Inc..
[430869]
Pt presented for elective hysteroscopy, and had laminaria placed prior to procedure. Hysteroscopy performed the next day. String lether to laminaria disconnected with effort to retrieve laminaria. Attempt then made to retrieve device with ring forceps, and laminaria broke into many pieces. Md believed that all of laminaria was retrieved, and proceeded with hysteroscopy. Pt reported that piece of laminaria was expelled 2005, after 2 months of bleeding and cramping.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037409 |
| MDR Report Key | 653266 |
| Date Received | 2005-12-08 |
| Date of Report | 2005-12-08 |
| Date of Event | 2005-08-25 |
| Date Added to Maude | 2005-12-19 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAMINARIA JAPONICA |
| Generic Name | DILATERIA |
| Product Code | HDY |
| Date Received | 2005-12-08 |
| Model Number | THIN |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 642733 |
| Manufacturer | MILEX PRODUCTS, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-12-08 |